Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis (PALEKONA)
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis (PALEKONA)
ClinicalTrials.gov ID: NCT06029972
Sponsor Gilead: Sciences
Information provided by: Gilead Sciences (Responsible Party)
Last Update Posted: 2023-09-08
Brief Summary:
The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo.
The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.
OFFICIAL TITLE
A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis
INTERVENTION / TREATMENT
Drug: Tilpisertib Fosmecarbil
Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Estimated) | 2023-10 |
| Primary Completion (Estimated) | 2025-06 |
| Study Completion (Estimated) |
2026-06
|
| Enrollment (Estimated) | 176 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
GS-US-457-6411
2022-501119-14 (Other Identifier) (OTHER: European Medicines Agency)
|