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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)

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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10. Juli10. Jul

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)

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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10. Juli10. Jul

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)

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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10. Juli10. Jul

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

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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7. Juli7. Jul

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)

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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7. Juli7. Jul

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

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, RO: 21/03/2024, DE: 20/03/2024, HU: 04/04/2024, PL: 25/03/2024, ES: 21/03/2024
Last updated date: 06/07/2026Den kompletten Artikel zeigen

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7. Juli7. Jul

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

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, RO: 21/03/2024, HU: 04/04/2024, DE: 20/03/2024, PL: 25/03/2024, ES: 21/03/2024
Last updated date: 02/07/2026Den kompletten Artikel zeigen

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3. Juli3. Jul

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Trial number: 2025-522567-15-00
Overall trial status: Ongoing, recruiting
Trial title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Medical conditions: Plaque Psoriasis
Status in each country: Spain:Authorised, recruiting, Poland:Ongoing, recruiting, Germany:Ongoing, recruiting, Italy:Authorised, recruitment pending
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Part A: Coprimary Endpoints (vs Placebo) at Week 16 • sPGA 0/1 response: Proportion of participants achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline. • PASI-75 response: Proportion of participants achieving ≥75% improvement from baseline in PASI score. Part A Cohort 1: Includes adolescent participants aged 12 to <18 years. Part A Cohort 2: Includes children participants aged 4 to <12 years., Part B: PK Primary Endpoints • PK parameters (that is Cmax, Tmax, AUC0-Last) of zasocitinib on Day 7. Part B: Includes only children participants aged 4 to <12 years. Part B participants will be separate from Part A Cohort 2 participants.
Secondary end point: Part A: Key Secondary Efficacy Endpoints (vs Placebo) at Week 16 • PASI-90 response: Proportion of participants achieving PASI-90. • Enhanced sPGA response: Proportion of participants achieving an sPGA of clear (0). • PASI-100 response: Proportion of participants achieving PASI-100., Part A: Additional Secondary Efficacy Endpoints (vs Placebo) at Week 16 • ssPGA response: Proportion of participants achieving an ssPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline for participants with a baseline ssPGA ≥3. • Change and percent change from baseline in BSA affected by psoriasis., • DLQI response: Proportion of participants with a DLQI score of 0/1 (for participants with a baseline DLQI score ≥2). • CDLQI response: Proportion of participants with a CDLQI score of 0/1 (for participants with a baseline CDLQI score ≥2). • Change from baseline in DLQI. • Change from baseline in CDLQI., Part A (Cohort 1 only): Additional Secondary Efficacy Endpoints (vs Placebo) at Week 16 • Itch NRS response: Proportions of participants achieving a ≥4-point improvement in Itch NRS for participants in Cohort 1 who had an itch NRS ≥4 at baseline. • Change and percent change from baseline in Itch NRS for participants in Cohort 1., Parts A and B: Additional Secondary Efficacy Endpoints at Each Scheduled Visit Over the Duration of the Open-Label Period • PASI-75 response: Proportion of participants achieving PASI-75. • PASI-90 response: Proportion of participants achieving PASI-90. • PASI-100 response: Proportion of participants achieving PASI-100., • sPGA 0/1 response: Proportion of participants achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline. • Enhanced sPGA response: Proportion of participants achieving an sPGA of clear (0)., • ssPGA response: Proportion of participants achieving an ssPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline for participants with a baseline ssPGA ≥3. • Change and percent change from baseline in BSA affected by psoriasis., • DLQI response: Proportion of participants with a DLQI score of 0/1 (for participants with a baseline DLQI score ≥2). • CDLQI response: Proportion of participants with a CDLQI score of 0/1 (for participants with a baseline CDLQI score ≥2)., • Change from baseline in DLQI. • Change from baseline in CDLQI., Part A (Cohort 1 only): Additional Secondary Efficacy Endpoints at Each Scheduled Visit Over the Duration of the Open- Label Period • Itch NRS responses: Proportions of participants achieving a ≥4-point improvement in Itch NRS for participants in Cohort 1 who had an itch NRS ≥4 at baseline. • Change and percent change from baseline in Itch NRS for participants in Cohort 1., Part A: Additional Secondary PK Endpoint • Plasma concentrations of zasocitinib in participants receiving active treatment., Part B: Additional Secondary Endpoint • Acceptability/palatability assessment scores.
Age of participants: 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 54
Sponsor: Takeda Development Center Americas Inc.
Sponsor type: Pharmaceutical company
Trial product: ZASOCITINIB, Matching Placebo for TAK-279
Results posted: No
Overall decision date: 01/04/2026
Countries decision date: DE: 07/04/2026, IT: 01/04/2026, ES: 06/04/2026, PL: 03/04/2026
Last updated date: 22/06/2026Den kompletten Artikel zeigen

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2. Juli2. Jul

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Trial number: 2025-522567-15-00
Overall trial status: Ongoing, recruiting
Trial title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Medical conditions: Plaque Psoriasis
Status in each country: Spain:Authorised, recruiting, Poland:Ongoing, recruiting, Germany:Ongoing, recruiting, Italy:Authorised, recruitment pending
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Part A: Coprimary Endpoints (vs Placebo) at Week 16 • sPGA 0/1 response: Proportion of participants achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline. • PASI-75 response: Proportion of participants achieving ≥75% improvement from baseline in PASI score. Part A Cohort 1: Includes adolescent participants aged 12 to <18 years. Part A Cohort 2: Includes children participants aged 4 to <12 years., Part B: PK Primary Endpoints • PK parameters (that is Cmax, Tmax, AUC0-Last) of zasocitinib on Day 7. Part B: Includes only children participants aged 4 to <12 years. Part B participants will be separate from Part A Cohort 2 participants.
Secondary end point: Part A: Key Secondary Efficacy Endpoints (vs Placebo) at Week 16 • PASI-90 response: Proportion of participants achieving PASI-90. • Enhanced sPGA response: Proportion of participants achieving an sPGA of clear (0). • PASI-100 response: Proportion of participants achieving PASI-100., Part A: Additional Secondary Efficacy Endpoints (vs Placebo) at Week 16 • ssPGA response: Proportion of participants achieving an ssPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline for participants with a baseline ssPGA ≥3. • Change and percent change from baseline in BSA affected by psoriasis., • DLQI response: Proportion of participants with a DLQI score of 0/1 (for participants with a baseline DLQI score ≥2). • CDLQI response: Proportion of participants with a CDLQI score of 0/1 (for participants with a baseline CDLQI score ≥2). • Change from baseline in DLQI. • Change from baseline in CDLQI., Part A (Cohort 1 only): Additional Secondary Efficacy Endpoints (vs Placebo) at Week 16 • Itch NRS response: Proportions of participants achieving a ≥4-point improvement in Itch NRS for participants in Cohort 1 who had an itch NRS ≥4 at baseline. • Change and percent change from baseline in Itch NRS for participants in Cohort 1., Parts A and B: Additional Secondary Efficacy Endpoints at Each Scheduled Visit Over the Duration of the Open-Label Period • PASI-75 response: Proportion of participants achieving PASI-75. • PASI-90 response: Proportion of participants achieving PASI-90. • PASI-100 response: Proportion of participants achieving PASI-100., • sPGA 0/1 response: Proportion of participants achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline. • Enhanced sPGA response: Proportion of participants achieving an sPGA of clear (0)., • ssPGA response: Proportion of participants achieving an ssPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline for participants with a baseline ssPGA ≥3. • Change and percent change from baseline in BSA affected by psoriasis., • DLQI response: Proportion of participants with a DLQI score of 0/1 (for participants with a baseline DLQI score ≥2). • CDLQI response: Proportion of participants with a CDLQI score of 0/1 (for participants with a baseline CDLQI score ≥2)., • Change from baseline in DLQI. • Change from baseline in CDLQI., Part A (Cohort 1 only): Additional Secondary Efficacy Endpoints at Each Scheduled Visit Over the Duration of the Open- Label Period • Itch NRS responses: Proportions of participants achieving a ≥4-point improvement in Itch NRS for participants in Cohort 1 who had an itch NRS ≥4 at baseline. • Change and percent change from baseline in Itch NRS for participants in Cohort 1., Part A: Additional Secondary PK Endpoint • Plasma concentrations of zasocitinib in participants receiving active treatment., Part B: Additional Secondary Endpoint • Acceptability/palatability assessment scores.
Age of participants: 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 54
Sponsor: Takeda Development Center Americas Inc.
Sponsor type: Pharmaceutical company
Trial product: ZASOCITINIB, Matching Placebo for TAK-279
Results posted: No
Overall decision date: 01/04/2026
Countries decision date: DE: 07/04/2026, IT: 01/04/2026, ES: 06/04/2026, PL: 03/04/2026
Last updated date: 22/06/2026View the full article

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2. Juli2. Jul

A phase 3B exploratory multicenter open-label study to evaluate the effect of bimekizumab on gene expression biomarkers in study participants with moderate to severe plaque psoriasis.

A phase 3B exploratory multicenter open-label study to evaluate the effect of bimekizumab on gene expression biomarkers in study participants with moderate to severe plaque psoriasis.

Trial number: 2023-506333-29-00
Overall trial status: Ongoing, recruiting
Trial title: A phase 3B exploratory multicenter open-label study to evaluate the effect of bimekizumab on gene expression biomarkers in study participants with moderate to severe plaque psoriasis.
Medical conditions: Psoriatic arthritis, Moderate to Severe Plaque Psoriasis
Status in each country: Poland:Ongoing, recruiting, Germany:Ongoing, recruiting
Trial phase: Phase III and phase IV (Integrated)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Baseline and Week 48 using preselected genes based on Bimekizumab mechanism of action and PSO disease biology pathways
Secondary end point: 1. Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU) 2. Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU 3. TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU
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: 46
Sponsor: UCB Biopharma
Sponsor type: Pharmaceutical company
Trial product: bimekizumab
Results posted: No
Overall decision date: 15/08/2024
Countries decision date: DE: 15/08/2024, PL: 26/08/2024
Last updated date: 07/03/2026View the full article

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8. März8. Mär

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis

Trial number: 2023-506296-97-00
Overall trial status: Ongoing, recruiting
Trial title: A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Germany:Ongoing, recruiting, Romania:Authorised, recruiting, Italy:Ongoing, recruiting, Belgium:Ongoing, recruiting, Poland:Ongoing, recruiting, Hungary:Ongoing, recruiting, Spain:Ongoing, recruiting
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Efficacy: Participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16., Efficacy: Participants achieving a sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16., Safety (LTE): AEs and SAEs through study completion., Safety (LTE): Monitoring of growth, including body weight and height and sexual maturation, through study completion.
Secondary end point: Efficacy: Participants achieving at least 90% improvement in PASI (PASI 90) Week 16., Efficacy: Change from baseline in PASI at Week 16., Efficacy: Change from baseline in BSA involvement at Week 16., Safety: Treatment emergent AEs and SAEs, laboratory parameters, physical examination, and vital signs through study completion., Safety: Participants with protective titers of antibodies to measles, tetanus, and pertussis at Week 16., Safety: Monitoring of growth including body weight and height, and sexual maturation through study completion., Efficacy (LTE): Participants achieving 75% improvement in PASI (PASI 75) over time through study completion., Efficacy (LTE): Participants achieving an sPGA score of 0 (clear) or 1(almost clear) with at least a 2-point reduction from baseline over time through study completion.
Age of participants: 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 145
Sponsor: Bristol-Myers Squibb Services Unlimited Company
Sponsor type: Pharmaceutical company
Trial product: Placebo to match deucravacitinib 2mg minitablets in sachet, oral use, Placebo to match deucravacitinib 6mg tablets in bottle, oral use, deucravacitinib, deucravacitinib
Results posted: No
Overall decision date: 08/10/2025
Countries decision date: BE: 08/10/2025, DE: 08/10/2025, HU: 10/10/2025, IT: 10/10/2025, RO: 13/10/2025, ES: 09/10/2025, PL: 10/10/2025
Last updated date: 13/10/2025View the full article

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6. März6. Mär

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Experienced Subjects with Active Psoriatic Arthritis I (INSPIRE 1)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Experienced Subjects with Active Psoriatic Arthritis I (INSPIRE 1)

Trial number: 2023-507415-35-00
Overall trial status: Ongoing, recruitment ended
Trial title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Experienced Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
Medical conditions: Psoriatic Arthritis
Status in each country: Czechia:Ended, Germany:Ended, Estonia:Ended, Spain:Ended, Slovakia:Ongoing, recruitment ended, Italy:Ended, Poland:Ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: The proportion of subjects who achieve ACR20 at Week 24
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: 204
Sponsor: Sun Pharmaceutical Industries Limited
Sponsor type: Pharmaceutical company
Trial product: Ilumetri 100 mg solution for injection in pre-filled syringe, tildrakizumab placebo solution for injection in pre-filled syringe
Results posted: No
Overall decision date: 31/05/2024
Countries decision date: PL: 21/06/2024, ES: 04/06/2024, IT: 01/07/2024, DE: 31/05/2024, CZ: 04/06/2024, SK: 31/05/2024, EE: 31/05/2024
Last updated date: 10/04/2025Den kompletten Artikel zeigen

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24. Februar24. Feb

Molecular Inflammation Board at the Center for Personalized Medicine

Molecular Inflammation Board at the Center for Personalized Medicine

Conditions: Psoriasis (PsO); Psoriasis Arthritis; Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); Spondylarthropathies
Interventions: Biological: Biologic Agent
Sponsors: University Hospital Tuebingen; University Hospital Freiburg; University Hospital Heidelberg; University Hospital Ulm
RecruitingKomplette Studien-Angaben zeigen

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20. August 202520. Aug

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Conditions: Plaque Psoriasis
Interventions: Drug: Deucravacitinib; Drug: Ustekinumab
Sponsors: Bristol-Myers Squibb
Not yet recruitingKomplette Studien-Angaben zeigen

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14. August 202514. Aug

A Phase 3, parallel-group, randomized, double-blind, 3-arm, placebo-controlled, multicenter study to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis who

A Phase 3, parallel-group, randomized, double-blind, 3-arm, placebo-controlled, multicenter study to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis who

Trial number: 2024-516213-20-00
Overall trial status: Ongoing, recruiting
Trial title: A Phase 3, parallel-group, randomized, double-blind, 3-arm, placebo-controlled, multicenter study to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis who are naive to biologic DMARDs
Medical conditions: Psoriatic arthritis
Status in each country: Hungary:Ongoing, recruiting, Romania:Ongoing, recruiting, Spain:Ongoing, recruiting, Greece:Authorised, recruitment pending, Latvia:Ongoing, recruiting, Lithuania:Ongoing, recruiting, Poland:Authorised, recruitment pending, Croatia:Authorised, recruiting, Czechia:Ongoing, recruiting, Finland:Ongoing, recruiting, Estonia:Ongoing, recruiting, France:Ongoing, recruiting, Slovakia:Ongoing, recruiting, Germany:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Portugal:Authorised, recruiting
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Proportion of participants achieving ACR50 (ie, ≥50% improvement on the ACR response criteria) at Week 16
Secondary end point: 1. Proportion of participants achieving ACR20 (ie, ≥20% improvement on the ACR response criteria) at Week 16, 2. Proportion of participants achieving Minimal Disease Activity (MDA) at Week 16, 3. Change from Baseline in Health Assessment Questionnaire—Disability Index (HAQ-DI) at Week 16, 4. Proportion of participants achieving a decrease of ≥90% in the Psoriasis Area and Severity Index (PASI90) response at Week 16 in the subgroup of participants with PsO involving ≥3% body surface area at Baseline, 5. Change from Baseline in SF-36 PCS at Week 16, 6. Change from Baseline to Week 16 in joint/bone structural damage (van der Heijde modified Total Sharp Score), 7. Incidence, relatedness, severity, and seriousness of TEAEs, 8. Withdrawal due to TEAEs, 9. Clinically relevant abnormalities in vital signs (blood pressure and heart rate) and body weight, 10. Clinically relevant abnormalities in 12-lead ECG variables, 11. Clinically relevant abnormalities in laboratory parameters (hematology, biochemistry, and urinalysis)
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: 590
Sponsor: MoonLake Immunotherapeutics AG
Sponsor type: Pharmaceutical company
Trial product: Placebo is a sterile solution in a single use prefilled syringe (pfs) intended for subcutaneous administration, Sonelokimab
Results posted: No
Overall decision date: 10/03/2025
Countries decision date: BG: 12/03/2025, HR: 17/03/2025, CZ: 12/03/2025, EE: 17/03/2025, FR: 10/03/2025, HU: 14/03/2025, LV: 12/03/2025, LT: 13/03/2025, PT: 13/03/2025, ES: 11/03/2025, SK: 10/03/2025, FI: 21/03/2025, RO: 17/03/2025, PL: 26/03/2025, DE: 13/03/2025, GR: 11/03/2025
Last updated date: 30/05/2025Den kompletten Artikel zeigen

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31. Mai 20251 J.

A Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm, to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years a

A Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm, to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years a

Trial number: 2024-516219-25-00
Overall trial status: Ongoing, recruiting
Trial title: A Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm, to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis and previous inadequate response or intolerance to tumor necrosis factor-α inhibitors
Medical conditions: psoriatic arthritis
Status in each country: Spain:Ongoing, recruiting, Czechia:Ongoing, recruiting, Bulgaria:Ongoing, recruiting, Poland:Ongoing, recruiting, Hungary:Ongoing, recruiting, France:Authorised, recruiting, Germany:Ongoing, recruiting
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: 1. Proportion of participants achieving ACR50 (ie, ≥50% response on the ACR response criteria) at Week 16
Secondary end point: 1. Proportion of participants achieving ACR20 (ie, ≥20% response on the ACR response criteria) at Week 16, 2. Proportion of participants achieving Minimal Disease Activity (MDA) at Week 16, 3. Change from Baseline in Health Assessment Questionnaire—Disability Index (HAQ-DI) at Week 16, 4. Proportion of participants achieving PASI90 response at Week 16 in the subset of participants with PsO involving ≥3% body surface area at Baseline, 5. Change from Baseline in SF-36 PCS at Week 16, 6. Proportion of participants achieving ACR50 at Week 16, 7. Incidence, relatedness, severity, and seriousness of TEAEs, 8. Withdrawal due to TEAEs, 9. Clinically relevant abnormalities in vital signs (blood pressure and heart rate) and body weight, 10. Clinically relevant abnormalities in 12-lead ECG variables, 11. Clinically relevant abnormalities in laboratory parameters (hematology, biochemistry, and urinalysis)
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: 372
Sponsor: MoonLake Immunotherapeutics AG
Sponsor type: Pharmaceutical company
Trial product: Skyrizi 150 mg solution for injection in pre-filled syringe, Sonelokimab, Placebo is a sterile solution in a single use prefilled syringe (PFS) intended for subcutaneous administration., Sonelokimab
Results posted: No
Overall decision date: 07/03/2025
Countries decision date: BG: 12/03/2025, CZ: 11/03/2025, FR: 07/03/2025, DE: 10/03/2025, HU: 13/03/2025, ES: 10/03/2025, PL: 16/03/2025
Last updated date: 30/05/2025Den kompletten Artikel zeigen

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31. Mai 20251 J.

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)

Trial number: 2023-507193-40-00
Overall trial status: Authorised, recruiting
Trial title: A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Bulgaria:Ongoing, recruitment ended, Belgium:Authorised, recruiting, Portugal:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Achievement of co-primary endpoint (PASI-75 & sPGA-0/1) at Week 16 compared with Placebo
Secondary end point: Week 16 Endpoints: *Achievement of PASI-90, PASI-100, sPGA-0 PASI-75 and sPGA-0/1 compared to apremilast ss-PGA-0/1 PROs: PSSD-0 and DLQI-0/1 *Change from baseline in %BSA Pruritis NRS score, Week 24 Endpoints compared to apremilast: *Achievement of PASI-75, PASI-90, PASI-100 sPGA-0/1, sPGA-0 ss-PGA-0/1 PROs: PSSD-0 and DLQI-0/1 *Change from baseline %BSA Pruritis NRS score
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: 389
Sponsor: Alumis Inc.
Sponsor type: Pharmaceutical company
Trial product: Otezla 10mg, 20mg, 30 mg film-coated tablets, Otezla 30 mg film-coated tablets, ESK-001, Name: ESK-001 placebo Pharmaceutical Form: film-coated tablet Route of administration: Oral use Maximum duration of treatment: 16 weeks, Name: apremilast placebo Pharmaceutical form: Only over-encapsulating capsule shell containing backfill, no tablet Route of administration: oral use Maximum duration of treatment: 16 weeks, Otezla 30 mg film-coated tablets
Results posted: No
Overall decision date: 10/12/2024
Countries decision date: BE: 10/12/2024, DE: 10/12/2024, CZ: 11/12/2024, PT: 11/12/2024, BG: 16/12/2024, PL: 16/12/2024
Last updated date: 11/03/2025Den kompletten Artikel zeigen

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31. Mai 20251 J.

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Conditions: Plaque Psoriasis
Interventions: Drug: Deucravacitinib; Other: Placebo
Sponsors: Bristol-Myers Squibb
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29. Mai 20251 J.

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

Trial number: 2022-502361-15-00
Overall trial status: Ongoing, recruitment ended
Trial title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
Medical conditions: Moderate-to-Severe Plaque Psoriasis
Status in each country: Hungary:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Sweden:Ongoing, recruitment ended, France:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Finland:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Adverse events and serious adverse events
Secondary end point: sPGA 0/1 response, PASI 75 response
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: 664
Sponsor: Bristol Myers Squibb International Corporation
Sponsor type: Pharmaceutical company
Trial product: Placebo to match BMS 986165 tablet, deucravacitinib
Results posted: No
Overall decision date: 05/04/2024
Countries decision date: FR: 21/05/2024, HU: 05/04/2024, PL: 12/04/2024, CZ: 09/04/2024, ES: 09/04/2024, FI: 09/04/2024, SE: 05/04/2024, DE: 10/04/2024
Last updated date: 27/05/2025Den kompletten Artikel zeigen

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28. Mai 20251 J.

22104: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis

22104: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis

Trial number: 2022-501362-22-00
Overall trial status: Ended
Trial title: 22104: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis
Medical conditions: Psoriatic Arthritis
Status in each country: Hungary:Ended, Czechia:Ended, Poland:Ended, Spain:Ended, Germany:Ended, Bulgaria:Ended
Trial phase: Phase II and Phase III (Integrated)
Therapeutic Areas: Diseases [C] - Musculoskeletal Diseases [C05]
Primary end point: ACR50 at Week 16
Secondary end point: • Resolution of enthesitis (LEI = 0) at Week 16 • PsAID response at Week 16 • PASI90 at Week 16 • HAQ-DI change from baseline to Week 16 • ACR20 at Week 16 • TEAEs, events of interest, and SAEs • Laboratory values and vital signs at collected timepoints • Treatment-emergent ADAs
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: 78
Sponsor: Acelyrin Inc., Acelyrin Inc.
Sponsor type: Pharmaceutical company, Pharmaceutical company
Trial product: Izokibep, Placebo
Results posted: Yes
Overall decision date: 29/03/2023
Countries decision date: PL: 03/04/2023, DE: 29/03/2023, HU: 30/03/2023, ES: 03/04/2023, CZ: 30/03/2023, BG: 03/04/2023
Last updated date: 16/10/2024Den kompletten Artikel zeigen

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28. Mai 20251 J.