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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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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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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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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
Not yet recruitingDen kompletten Artikel zeigen
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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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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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