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Neu registrierte Studien in Deutschland

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis involving Special Areas

Trial number: 2023-505122-34-00
Overall trial status: Ongoing, recruitment ended
Trial title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis involving Special Areas
Medical conditions: Plaque Psoriasis
Status in each country: Spain:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: IGA (overall) score of 0 or 1 and a ≥2-grade improvement from baseline at Week 16.
Secondary end point: N/A
Age of participants: 65+ years, 18-64 years, 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 146
Sponsor: Janssen - Cilag International
Sponsor type: Pharmaceutical company
Trial product: JNJ-77242113, Film-Coated Tablet without JNJ-77242113
Results posted: No
Overall decision date: 27/11/2023
Countries decision date: PL: 30/11/2023, ES: 01/12/2023, DE: 28/11/2023, HU: 04/12/2023
Last updated date: 25/08/2026Den kompletten Artikel zeigen
Redaktion

A Multicenter, Randomized, Double-blind, Placebo- controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in Participants with Moderate to Severe Plaque Psoriasis

Trial number: 2022-502249-90-00
Overall trial status: Ended
Trial title: A Multicenter, Randomized, Double-blind, Placebo- controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in Participants with Moderate to Severe Plaque Psoriasis
Medical conditions: Plaque Psoriasis
Status in each country: Spain:Ended, Poland:Ended, Hungary:Ended, Czechia:Ended, Germany:Ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: • Proportion of participants achieving ≥75% reduction in Psoriasis Area of Severity Index score (PASI-75) at Week 12 • Incidence proportion of TEAEs, SAEs, and TEAEs leading to discontinuation
Secondary end point: • Proportion of participants in each DC-806 treatment group achieving PASI-75 at Week 12 • Proportion of participants achieving an sPGA score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from Baseline at Week 12, • Proportion of participants achieving ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score (PASI-50, PASI-75, PASI-90, and PASI-100, respectively) at all scheduled timepoints • Proportion of participants achieving an sPGA score of 0 or 1 at all scheduled timepoints, • Change and percent change from Baseline in PASI score at all scheduled timepoints • Change and percent change from Baseline in the percentage of BSA affected at all scheduled timepoints • Measurement of plasma concentration of DC-806 at scheduled timepoints
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 206
Sponsor: DICE Therapeutics Inc.
Sponsor type: Pharmaceutical company
Trial product: DC-806 Placebo tablets, DC-806, DC-806, DC-806, DC-806
Results posted: Yes
Overall decision date: 17/08/2023
Countries decision date: HU: 18/08/2023, PL: 21/08/2023, ES: 18/08/2023, DE: 21/08/2023, CZ: 17/08/2023
Last updated date: 22/04/2024Den kompletten Artikel zeigen
Redaktion

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

Trial number: 2023-503766-24-00
Overall trial status: Authorised, recruiting
Trial title: A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Romania:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Germany:Ongoing, recruiting, Spain:Ongoing, recruiting, Czechia:Ongoing, recruiting, France:Ongoing, recruiting, Hungary:Ongoing, recruiting, Italy:Ongoing, recruiting, Sweden:Authorised, recruiting, Poland:Authorised, recruitment pending, Denmark:Ongoing, recruiting, Belgium:Authorised, recruiting
Trial phase: Phase III and phase IV (Integrated)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
Secondary end point: Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster, SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation, Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 1289
Sponsor: Bristol-Myers Squibb Services Unlimited Company
Sponsor type: Pharmaceutical company
Trial product: USTEKINUMAB, USTEKINUMAB, deucravacitinib
Results posted: No
Overall decision date: 19/01/2026
Countries decision date: BE: 02/02/2026, BG: 22/01/2026, SE: 02/02/2026, PL: 26/01/2026, HU: 23/01/2026, RO: 26/01/2026, CZ: 16/02/2026, FR: 02/02/2026, DK: 02/02/2026, ES: 26/01/2026, DE: 20/01/2026, IT: 02/02/2026
Last updated date: 24/08/2026Den kompletten Artikel zeigen
Redaktion

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

Trial number: 2023-503766-24-00
Overall trial status: Authorised, recruiting
Trial title: A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Romania:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Germany:Ongoing, recruiting, Spain:Ongoing, recruiting, Czechia:Ongoing, recruiting, France:Ongoing, recruiting, Hungary:Ongoing, recruiting, Italy:Ongoing, recruiting, Sweden:Authorised, recruiting, Poland:Authorised, recruitment pending, Denmark:Ongoing, recruiting, Belgium:Authorised, recruiting
Trial phase: Phase III and phase IV (Integrated)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
Secondary end point: Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster, SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation, Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 1289
Sponsor: Bristol-Myers Squibb Services Unlimited Company
Sponsor type: Pharmaceutical company
Trial product: USTEKINUMAB, USTEKINUMAB, deucravacitinib
Results posted: No
Overall decision date: 19/01/2026
Countries decision date: BE: 02/02/2026, BG: 22/01/2026, SE: 02/02/2026, PL: 26/01/2026, HU: 23/01/2026, RO: 26/01/2026, CZ: 16/02/2026, FR: 02/02/2026, DK: 02/02/2026, ES: 26/01/2026, DE: 20/01/2026, IT: 02/02/2026
Last updated date: 24/08/2026View the full article
Redaktion

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Dose-Range Finding Study of ORKA-001 in Participants with Moderate-to-Severe Plaque Psoriasis

Trial number: 2025-523797-17-00
Overall trial status: Ongoing, recruitment ended
Trial title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Dose-Range Finding Study of ORKA-001 in Participants with Moderate-to-Severe Plaque Psoriasis
Medical conditions: Moderate-to-Severe Plaque Psoriasis
Status in each country: Germany:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16: The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease) (Time Frame: Week 16)
Secondary end point: Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16: The Investigator Global Assessment (IGA) documents the Investigator’s assessment of the participant’s psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant’s psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). (Time Frame: Week 16), Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16 (Time Frame: Week 16), Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16 (Time Frame: Week 16), Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100 (Time Frame: Week 100), Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100 (Time Frame: Week 100), Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100 (Time Frame: Week 100), Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100 (Time Frame: Week 100), Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100 (Time Frame: Week 100), Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and TEAEs of Special Interest (TEAESIs): Incidence of treatment adverse events, treatment adverse events of special interest, and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms. (Time Frame: Day 1 through Week 100)
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 32
Sponsor: Oruka Therapeutics Inc.
Sponsor type: Pharmaceutical company
Trial product: Placebo for ORKA-001, ORKA-001
Results posted: No
Overall decision date: 08/05/2026
Countries decision date: DE: 08/05/2026, ES: 11/05/2026
Last updated date: 19/08/2026Den kompletten Artikel zeigen
Redaktion

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis with Randomized Withdrawal and Retreatment

Trial number: 2023-505120-59-00
Overall trial status: Ongoing, recruitment ended
Trial title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis with Randomized Withdrawal and Retreatment
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Germany:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, France:Ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: IGA score of 0 or 1 and a ≥2-grade improvement from baseline at Week 16., PASI 90 at Week 16.
Secondary end point: N/A
Age of participants: 0-17 years, 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 281
Sponsor: Janssen - Cilag International
Sponsor type: Pharmaceutical company
Trial product: JNJ-77242113, Film-Coated Tablet without JNJ-77242113
Results posted: No
Overall decision date: 19/12/2023
Countries decision date: IT: 08/01/2024, FR: 03/01/2024, HU: 20/12/2023, ES: 22/12/2023, DE: 19/12/2023, PL: 21/12/2023
Last updated date: 19/08/2026Den kompletten Artikel zeigen
Redaktion

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Trial number: 2024-515706-77-00
Overall trial status: Authorised, recruiting
Trial title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Hungary:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Belgium:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Denmark:Ongoing, recruitment ended, Austria:Ended, Poland:Ongoing, recruitment ended, Portugal:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: IGA score of 0 or 1 and a ≥2 grade improvement from baseline at Week 16., PASI 90 at Week 16.
Secondary end point: N/A
Age of participants: 65+ years, 0-17 years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 488
Sponsor: Janssen Cilag International
Sponsor type: Pharmaceutical company
Trial product: STELARA 90 mg solution for injection in pre-filled syringe, Film-Coated Tablet without JNJ-77242113, Solution for injection without Ustekinumab 45, JNJ-77242113, STELARA 45 mg solution for injection, Solution for injection in pre-filled syringe without Ustekinumab 90
Results posted: No
Overall decision date: 06/05/2025
Countries decision date: AT: 12/05/2025, DK: 06/05/2025, PL: 13/05/2025, ES: 07/05/2025, PT: 19/05/2025, BE: 08/05/2025, HU: 07/05/2025, DE: 06/05/2025
Last updated date: 18/08/2026Den kompletten Artikel zeigen
Redaktion

Prospective Analysis of Blood Flow Restriction Training in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Compared to Conventional Strength Training

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis
Interventions: Behavioral: Blood Flow Restriction Training (BFRT); Behavioral: Conventional Strength Training
Sponsors: University of Bonn
CompletedKomplette Studien-Angaben zeigen
Redaktion

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Trial number: 2023-507039-39-00
Overall trial status: Authorised, recruiting
Trial title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Italy:Not authorised, Germany:Ongoing, recruitment ended, Romania:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: IGA score of 0 or 1 and a ≥2-grade improvement from baseline at Week 16., PASI 90 at Week 16.
Secondary end point: N/A
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 342
Sponsor: Janssen - Cilag International
Sponsor type: Pharmaceutical company
Trial product: Film-Coated Tablet without JNJ-77242113, Film-Coated Tablet without Deucravacitinib, DEUCRAVACITINIB, JNJ-77242113
Results posted: No
Overall decision date: 19/03/2024
Countries decision date: IT: 21/03/2024, HU: 04/04/2024, PL: 25/03/2024, RO: 21/03/2024, ES: 21/03/2024, DE: 20/03/2024
Last updated date: 18/08/2026Den kompletten Artikel zeigen
Redaktion

An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment

Trial number: 2023-504417-67-00
Overall trial status: Ongoing, recruiting
Trial title: An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment
Medical conditions: Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Severe Chronic Plaque Psoriasis, Moderate to severe Chronic Plaque Psoriasis, Juvenile idiopathic Arthritis
Status in each country: Czechia:Ongoing, recruiting, Spain:Ongoing, recruiting, Poland:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Italy:Ended, Portugal:Ended, Belgium:Authorised, recruitment pending, Germany:Authorised, recruitment pending
Trial phase: Therapeutic use (Phase IV)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
Secondary end point: N/A
Age of participants: 18-64 years, 65+ years, 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 328
Sponsor: Novartis Pharma AG
Sponsor type: Pharmaceutical company
Trial product: SECUKINUMAB, SECUKINUMAB
Results posted: No
Overall decision date: 21/08/2023
Countries decision date: IT: 09/07/2024, PT: 12/06/2024, BG: 20/09/2023, CZ: 21/08/2023, PL: 23/08/2023, ES: 22/08/2023, DE: 06/08/2026, BE: 19/11/2025
Last updated date: 06/08/2026Den kompletten Artikel zeigen
Redaktion

OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1

Trial number: 2022-500408-22-00
Overall trial status: Ongoing, recruiting
Trial title: OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1).
Medical conditions: Plaque Psoriasis
Status in each country: Germany:Ongoing, recruiting, Spain:Ongoing, recruiting, Poland:Ongoing, recruiting
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Number of Participants With Adverse Events
Secondary end point: N/A
Age of participants: 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 70
Sponsor: Abbvie Deutschland GmbH & Co. KG
Sponsor type: Pharmaceutical company
Trial product: Risankizumab, ABBV-066
Results posted: No
Overall decision date: 19/07/2022
Countries decision date: DE: 19/07/2022, ES: 19/07/2022, PL: 19/07/2022
Last updated date: 06/08/2026Den kompletten Artikel zeigen
Redaktion

OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1

Trial number: 2022-500408-22-00
Overall trial status: Ongoing, recruiting
Trial title: OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1).
Medical conditions: Plaque Psoriasis
Status in each country: Germany:Ongoing, recruiting, Spain:Ongoing, recruiting, Poland:Ongoing, recruiting
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Number of Participants With Adverse Events
Secondary end point: N/A
Age of participants: 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 70
Sponsor: Abbvie Deutschland GmbH & Co. KG
Sponsor type: Pharmaceutical company
Trial product: Risankizumab, ABBV-066
Results posted: No
Overall decision date: 19/07/2022
Countries decision date: DE: 19/07/2022, ES: 19/07/2022, PL: 19/07/2022
Last updated date: 06/08/2026View the full article
Redaktion

EffisayilTM ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with Generalized Pustular Psoriasis (GPP)

Trial number: 2023-509216-28-00
Overall trial status: Ongoing, recruitment ended
Trial title: EffisayilTM ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with Generalized Pustular Psoriasis (GPP)
Medical conditions: Generalized Pustular Psoriasis
Status in each country: France:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Belgium:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment
Secondary end point: The reoccurrence of a GPP flare defined by GPPGA, Time to first achievement of a GPPGA score of 0 or 1 in patients who received flare rescue treatment, A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit in patients who received flare rescue treatment, Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit in patients who received flare rescue treatment
Age of participants: 65+ years, 0-17 years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 25
Sponsor: Leo Pharma A/S
Sponsor type: Pharmaceutical company
Trial product: Spesolimab
Results posted: No
Overall decision date: 12/02/2024
Countries decision date: FR: 13/02/2024, DE: 13/02/2024, BE: 19/02/2024, ES: 12/02/2024, IT: 18/03/2024
Last updated date: 03/08/2026Den kompletten Artikel zeigen
Redaktion

EffisayilTM ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with Generalized Pustular Psoriasis (GPP)

Trial number: 2023-509216-28-00
Overall trial status: Ongoing, recruitment ended
Trial title: EffisayilTM ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with Generalized Pustular Psoriasis (GPP)
Medical conditions: Generalized Pustular Psoriasis
Status in each country: France:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Belgium:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment
Secondary end point: The reoccurrence of a GPP flare defined by GPPGA, Time to first achievement of a GPPGA score of 0 or 1 in patients who received flare rescue treatment, A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit in patients who received flare rescue treatment, Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit in patients who received flare rescue treatment
Age of participants: 65+ years, 0-17 years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 25
Sponsor: Leo Pharma A/S
Sponsor type: Pharmaceutical company
Trial product: Spesolimab
Results posted: No
Overall decision date: 12/02/2024
Countries decision date: FR: 13/02/2024, DE: 13/02/2024, BE: 19/02/2024, ES: 12/02/2024, IT: 18/03/2024
Last updated date: 28/07/2026Den kompletten Artikel zeigen
Redaktion

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants with Moderate-to-Severe Plaque Psoriasis

Trial number: 2024-512207-39-00
Overall trial status: Ended
Trial title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants with Moderate-to-Severe Plaque Psoriasis
Medical conditions: Plaque Psoriasis
Status in each country: Hungary:Ended, Poland:Ended, Czechia:Ended, Germany:Ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Proportion of participants achieving PASI 75 at Week 12
Secondary end point: 1. Proportion of participants achieving: • an sPGA score of 0 or 1 with ≥2 grade improvement from baseline at Week 12 • ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score at all scheduled timepoints • an sPGA score of 0 or 1 at all scheduled timepoints • Mean change and percent change from baseline in PASI score at all scheduled timepoints • Mean change and percent change from baseline in the percentage of BSA affected at all scheduled timepoints, 2. Summary of safety data, including number and proportion of: • TEAEs • SAEs • discontinuations due to TEAEs, 3. Measurement of plasma concentration of LY4100511 at scheduled timepoints to evaluate steady state maximum concentration (Cmax,ss) and trough concentration (Ctrough,ss) and associated intra-individual variability
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 134
Sponsor: Dice Therapeutics Inc.
Sponsor type: Pharmaceutical company
Trial product: Placebo tablets will be the same size, shape, and color as the active tablets and will consist of the compendial excipients present in the active tablets. Placebo tablets are supplied in the same packaging configuration as the active tablets.
Results posted: Yes
Overall decision date: 23/01/2025
Countries decision date: PL: 27/01/2025, HU: 24/01/2025, DE: 24/01/2025, CZ: 23/01/2025
Last updated date: 06/10/2025Den kompletten Artikel zeigen
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A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB COMPARED TO USTEKINUMAB IN CHILDREN AND ADOLESCENT FROM 6 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE

Trial number: 2023-503859-10-00
Overall trial status: Ongoing, recruitment ended
Trial title: A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB COMPARED TO USTEKINUMAB IN CHILDREN AND ADOLESCENT FROM 6 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Germany:Ongoing, recruitment ended, Belgium:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, France:Ended, Hungary:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Psoriasis Area Severity Index 90 (PASI90) response at Week 16, Investigator´s Global Assessment (IGA) 0/1 response at Week 16
Secondary end point: PASI75 response at Week 4, PASI100 response at Week 16, PASI90 response at Week 48, IGA 0/1 response at Week 48, PASI100 response at Week 48, IGA 0 response at Week 16, IGA 0 response at Week 48, Treatment-emergent adverse events (TEAE)s, Serious TEAEs, TEAEs leading to discontinuation of investigational medicinal product (IMP), TEAEs leading to withdrawal from the study, Selected safety topics of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease (IBD), and injection site reactions) with onset occurring from day of first dose through 20 weeks after final dose of IMP adjusted by duration of study participant exposure to IMP, Change from Baseline in vital signs, Change from Baseline in physical examination findings, Change from Baseline in height (growth assessment), Change from Baseline in weight (growth assessment), Change from Baseline in laboratory analyses (chemistry and hematology), Change from Baseline in Children’s Dermatology Life Quality Index (CDLQI) total score at Week 16, Change from Baseline in CDLQI total score at Week 48, Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile psoriatic arthritis (PsA) prior to Baseline, Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16, Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period, Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period
Age of participants: 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 122
Sponsor: UCB Biopharma
Sponsor type: Pharmaceutical company
Trial product: Placebo matching test and comparator. 0.9% sodium chloride solution for injection (unauthorized), ustekinumab, Placebo matching test and comparator. 0.9% sodium chloride solution for injection (authorized - MA number: 6697366.00.00), bimekizumab
Results posted: No
Overall decision date: 15/07/2024
Countries decision date: CZ: 17/07/2024, FR: 15/07/2024, HU: 17/07/2024, ES: 16/07/2024, IT: 13/09/2024, BE: 22/07/2024, PL: 22/07/2024, DE: 17/07/2024
Last updated date: 27/02/2026Den kompletten Artikel zeigen
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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Trial number: 2023-507039-39-00
Overall trial status: Authorised, recruiting
Trial title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Italy:Not authorised, Germany:Ongoing, recruitment ended, Romania:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: IGA score of 0 or 1 and a ≥2-grade improvement from baseline at Week 16., PASI 90 at Week 16.
Secondary end point: N/A
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 342
Sponsor: Janssen - Cilag International
Sponsor type: Pharmaceutical company
Trial product: JNJ-77242113, DEUCRAVACITINIB, Film-Coated Tablet without Deucravacitinib, Film-Coated Tablet without JNJ-77242113
Results posted: No
Overall decision date: 19/03/2024
Countries decision date: IT: 21/03/2024, DE: 20/03/2024, HU: 04/04/2024, PL: 25/03/2024, RO: 21/03/2024, ES: 21/03/2024
Last updated date: 20/07/2026Den kompletten Artikel zeigen
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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Trial number: 2023-505121-14-00
Overall trial status: Authorised, recruiting
Trial title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Italy:Not authorised, Hungary:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, France:Not authorised, Spain:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: IGA score of 0 or 1 and a ≥2-grade improvement from baseline at Week 16., PASI 90 at Week 16.
Secondary end point: N/A
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 320
Sponsor: Janssen - Cilag International
Sponsor type: Pharmaceutical company
Trial product: JNJ-77242113, DEUCRAVACITINIB, Film-Coated Tablet without JNJ-77242113, Film-Coated Tablet without Deucravacitinib
Results posted: No
Overall decision date: 17/01/2024
Countries decision date: FR: 22/01/2024, IT: 22/01/2024, DE: 28/05/2024, HU: 22/01/2024, PL: 07/02/2024, ES: 29/05/2024
Last updated date: 16/07/2026Den kompletten Artikel zeigen
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Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and ≥120 kg body weight; ADJUST - Phase 4 – efficacy, A randomised, double-blind, controlled, parallel group

Trial number: 2023-509668-11-00
Overall trial status: Ended
Trial title: Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and ≥120 kg body weight; ADJUST - Phase 4 – efficacy, A randomised, double-blind, controlled, parallel group, multi-centre trial
Medical conditions: Moderate-to-severe plaque psoriasis and a body weight ≥120 kg.
Status in each country: Czechia:Ended, Hungary:Ended, Italy:Ended, Germany:Ended, Belgium:Ended, Spain:Ended, Greece:Ended, Poland:Ended, France:Ended
Trial phase: Therapeutic use (Phase IV)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]
Primary end point: Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.
Secondary end point: Having static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 40., Having PASI 90 response at Week 52., Having sPGA score of 0 or 1 at Week 52., Having sPGA of genitalia (sPGA-G) of 0 or 1 at both Weeks 40 and 52., Having sPGA-G score of 0 or 1 at Week 40., Having sPGA-G score of 0 or 1 at Week 52., Having PASI 100 response at Week 40., Having PASI 100 response at Week 52., Change from baseline at Weeks 40 and 52 in PASI score., Change from baseline at Weeks 40 and 52 in affected body surface area (BSA)., Having Dermatology Life Quality Index (DLQI) total score of 0 or 1 at Week 40., Having DLQI total score of 0 or 1 at Week 52., Change from baseline at Weeks 40 and 52 in DLQI total score.
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 352
Sponsor: Leo Pharma A/S
Sponsor type: Pharmaceutical company
Trial product: Brodalumab 70 mg, The placebo presentation is a pre-filled syringe containing the same excipients in the same amounts as the IMP, without the active substance., Kyntheum 210 mg solution for injection in pre-filled syringe
Results posted: Yes
Overall decision date: 06/06/2024
Countries decision date: FR: 18/06/2024, PL: 21/06/2024, IT: 12/06/2024, GR: 22/07/2024, ES: 06/06/2024, BE: 06/06/2024, CZ: 10/06/2024, DE: 07/06/2024, HU: 06/06/2024
Last updated date: 21/11/2025Den kompletten Artikel zeigen
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EffisayilTM ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with Generalized Pustular Psoriasis (GPP)

Trial number: 2023-509216-28-00
Overall trial status: Ongoing, recruitment ended
Trial title: EffisayilTM ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with Generalized Pustular Psoriasis (GPP)
Medical conditions: Generalized Pustular Psoriasis
Status in each country: France:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Belgium:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment
Secondary end point: The reoccurrence of a GPP flare defined by GPPGA, Time to first achievement of a GPPGA score of 0 or 1 in patients who received flare rescue treatment, A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit in patients who received flare rescue treatment, Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit in patients who received flare rescue treatment
Age of participants: 65+ years, 0-17 years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 25
Sponsor: Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Sponsor type: Pharmaceutical company, Pharmaceutical company
Trial product: Spesolimab
Results posted: No
Overall decision date: 12/02/2024
Countries decision date: FR: 13/02/2024, DE: 13/02/2024, BE: 19/02/2024, ES: 12/02/2024, IT: 18/03/2024
Last updated date: 20/07/2026Den kompletten Artikel zeigen
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A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

Trial number: 2023-503766-24-00
Overall trial status: Ongoing, recruiting
Trial title: A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Romania:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Germany:Ongoing, recruiting, Spain:Ongoing, recruiting, Czechia:Ongoing, recruiting, France:Ongoing, recruiting, Hungary:Ongoing, recruiting, Italy:Ongoing, recruiting, Sweden:Authorised, recruitment pending, Poland:Authorised, recruitment pending, Denmark:Authorised, recruitment pending, Belgium:Authorised, recruiting
Trial phase: Phase III and phase IV (Integrated)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
Secondary end point: Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster, SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation, Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 1289
Sponsor: Bristol-Myers Squibb Services Unlimited Company
Sponsor type: Pharmaceutical company
Trial product: USTEKINUMAB, USTEKINUMAB, deucravacitinib
Results posted: No
Overall decision date: 19/01/2026
Countries decision date: ES: 26/01/2026, PL: 26/01/2026, DE: 20/01/2026, RO: 26/01/2026, DK: 02/02/2026, BE: 02/02/2026, FR: 02/02/2026, IT: 02/02/2026, CZ: 16/02/2026, BG: 22/01/2026, SE: 02/02/2026, HU: 23/01/2026
Last updated date: 20/04/2026Den kompletten Artikel zeigen
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An Extension Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy and Durability of Response to ESK-001 (ONWARD3)

Trial number: 2024-511166-36-00
Overall trial status: Authorised, recruiting
Trial title: An Extension Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy and Durability of Response to ESK-001 (ONWARD3)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Belgium:Ended, France:Ongoing, recruitment ended, Portugal:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Latvia:Ongoing, recruitment ended, Romania:Ended, Estonia:Ongoing, recruitment ended, Bulgaria:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended, Austria:Ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Incidence and severity of treatment-emergent adverse events and serious adverse events
Secondary end point: Long-term efficacy endpoints: * Achievement of ≥75%, ≥90%, and ≥100% reductions in PASI after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Achievement of sPGA-0, sPGA-0/1 and ssPGA after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Mean change from baseline in PASI %BSA, Clinical response endpoints: * Following ESK-001 withdrawal, loss of response in: PASI-75 sPGA-0/1 PASI-90 PASI-100 and median time to loss of response in PASI-75 and sPGA0/1. * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Clinical response endpoints (continued): * Lack of response at Week 24 in parent study followed by an achievement of response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Quality of life endpoints: * Achievement of the following after 24, 48, 72, 96 weeks of overall ESK-001 treatment: DLQI-0/1 Change from baseline in DLQI, PSSD, NRS (Pruritus, Joint Pain, and Joint Disease Activity), SF-36 * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: DLQI-0/1 4 point improvement in DLQI PSSD-0
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 931
Sponsor: Alumis Inc.
Sponsor type: Pharmaceutical company
Trial product: ESK-001 placebo / Pharmaceutical Form: Film-coated tablet / Route of administration: Oral use / Maximum duration of treatment: 24 weeks, ESK-001
Results posted: No
Overall decision date: 29/04/2025
Countries decision date: AT: 06/05/2025, BE: 29/04/2025, RO: 06/05/2025, EE: 06/05/2025, PT: 02/05/2025, FR: 29/04/2025, LV: 30/04/2025, ES: 30/04/2025, CZ: 30/04/2025, PL: 05/05/2025, HU: 05/05/2025, DE: 30/04/2025, BG: 08/05/2025
Last updated date: 09/07/2026Den kompletten Artikel zeigen
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A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

Trial number: 2023-503766-24-00
Overall trial status: Ongoing, recruiting
Trial title: A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Romania:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Germany:Ongoing, recruiting, Spain:Ongoing, recruiting, Czechia:Ongoing, recruiting, France:Ongoing, recruiting, Hungary:Ongoing, recruiting, Italy:Ongoing, recruiting, Sweden:Authorised, recruitment pending, Poland:Authorised, recruitment pending, Denmark:Authorised, recruitment pending, Belgium:Authorised, recruiting
Trial phase: Phase III and phase IV (Integrated)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
Secondary end point: Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster, SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation, Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 1289
Sponsor: Bristol-Myers Squibb Services Unlimited Company
Sponsor type: Pharmaceutical company
Trial product: USTEKINUMAB, USTEKINUMAB, deucravacitinib
Results posted: No
Overall decision date: 19/01/2026
Countries decision date: ES: 26/01/2026, PL: 26/01/2026, DE: 20/01/2026, RO: 26/01/2026, DK: 02/02/2026, BE: 02/02/2026, FR: 02/02/2026, IT: 02/02/2026, CZ: 16/02/2026, BG: 22/01/2026, SE: 02/02/2026, HU: 23/01/2026
Last updated date: 20/04/2026View the full article
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A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis

Trial number: 2024-512496-12-00
Overall trial status: Ongoing, recruitment ended
Trial title: A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Czechia:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Latvia:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended, Bulgaria:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, France:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Incidence of treatment-emergent adverses events (TEAEs), Incidence of serious adverse events (SAEs)
Secondary end point: Over the duration of the study: ≥75% improvement in Psoriasis Area and Severity Index (PASI-75), Over the duration of the study: Static Physician Global Assessment (sPGA) of clear (0) or almost clear (1) with a ≥2-point decrease from baseline
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 839
Sponsor: Takeda Development Center Americas Inc.
Sponsor type: Pharmaceutical company
Trial product: ZASOCITINIB
Results posted: No
Overall decision date: 16/01/2025
Countries decision date: HU: 17/01/2025, IT: 17/01/2025, DE: 20/01/2025, FR: 28/07/2025, ES: 20/01/2025, LV: 16/01/2025, BG: 21/01/2025, CZ: 17/01/2025, PL: 21/01/2025
Last updated date: 29/05/2026Den kompletten Artikel zeigen
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An Extension Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy and Durability of Response to ESK-001 (ONWARD3)

Trial number: 2024-511166-36-00
Overall trial status: Authorised, recruiting
Trial title: An Extension Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy and Durability of Response to ESK-001 (ONWARD3)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Belgium:Ended, France:Ongoing, recruitment ended, Portugal:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Latvia:Ongoing, recruitment ended, Romania:Ended, Estonia:Ongoing, recruitment ended, Bulgaria:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended, Austria:Ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Incidence and severity of treatment-emergent adverse events and serious adverse events
Secondary end point: Long-term efficacy endpoints: * Achievement of ≥75%, ≥90%, and ≥100% reductions in PASI after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Achievement of sPGA-0, sPGA-0/1 and ssPGA after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Mean change from baseline in PASI %BSA, Clinical response endpoints: * Following ESK-001 withdrawal, loss of response in: PASI-75 sPGA-0/1 PASI-90 PASI-100 and median time to loss of response in PASI-75 and sPGA0/1. * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Clinical response endpoints (continued): * Lack of response at Week 24 in parent study followed by an achievement of response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Quality of life endpoints: * Achievement of the following after 24, 48, 72, 96 weeks of overall ESK-001 treatment: DLQI-0/1 Change from baseline in DLQI, PSSD, NRS (Pruritus, Joint Pain, and Joint Disease Activity), SF-36 * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: DLQI-0/1 4 point improvement in DLQI PSSD-0
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 931
Sponsor: Alumis Inc.
Sponsor type: Pharmaceutical company
Trial product: ESK-001 placebo / Pharmaceutical Form: Film-coated tablet / Route of administration: Oral use / Maximum duration of treatment: 24 weeks, ESK-001
Results posted: No
Overall decision date: 29/04/2025
Countries decision date: AT: 06/05/2025, BE: 29/04/2025, RO: 06/05/2025, LV: 30/04/2025, EE: 06/05/2025, PT: 02/05/2025, FR: 29/04/2025, ES: 30/04/2025, CZ: 30/04/2025, PL: 05/05/2025, HU: 05/05/2025, DE: 30/04/2025, BG: 08/05/2025
Last updated date: 06/07/2026Den kompletten Artikel zeigen
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