Trials / Terminated
TerminatedNCT04130919
Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis
A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic Score (MCS) in adults with moderately to severely active ulcerative colitis (UC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tilpisertib | Tablets administered orally once daily |
| DRUG | Placebo | Tablets administered orally once daily |
Timeline
- Start date
- 2019-12-20
- Primary completion
- 2021-02-25
- Completion
- 2021-12-14
- First posted
- 2019-10-18
- Last updated
- 2022-08-24
- Results posted
- 2022-08-24
Locations
49 sites across 9 countries: United States, Australia, Austria, Canada, France, Germany, Italy, Poland, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04130919. Inclusion in this directory is not an endorsement.