Trials / Active Not Recruiting
Active Not RecruitingNCT05785611
A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis
A Phase 3 Randomized, Placebo-controlled, Double-blind, Parallel-group Program to Evaluate Efficacy and Safety of Filgotinib in Adult Subjects With Active Axial Spondyloarthritis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 495 (actual)
- Sponsor
- Alfasigma S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use. The study will also be comparing 200 mg with 100 mg filgotinib a day to see if the lower dose also helps to treat axSpA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Filgotinib | Tablets administered orally once daily |
| DRUG | Placebo | Tablets administered orally once daily |
Timeline
- Start date
- 2023-04-05
- Primary completion
- 2024-09-04
- Completion
- 2028-12-01
- First posted
- 2023-03-27
- Last updated
- 2025-12-04
Locations
123 sites across 18 countries: Belgium, Bulgaria, Czechia, Estonia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Philippines, Poland, Romania, South Africa, South Korea, Spain, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT05785611. Inclusion in this directory is not an endorsement.