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: 10/04/2025
Es gibt noch keine Rezensionen.