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: 18/08/2026
Es gibt noch keine Rezensionen.