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NCT06029972 · ClinicalTrials.gov registry record · Phase 2
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 176
- Enrollment target
- 20
- Study locations
NCT06029972: Recruiting Phase 2 study of Ulcerative Colitis, sponsored by Gilead Sciences.
NCT06029972 is a Phase 2 study of Ulcerative Colitis that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 176 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06029972, a Phase 2 study of Ulcerative Colitis, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 176 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Clinical Response is defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score, Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1. The modified Mayo Clinic Score is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tilpisertib Fosmecarbil
Study Locations (20)
California
- GastroSb Weight Loss Clinic - Chula Vista
- Southern California Research Centers - Coronado
- VVCRD Research - Garden Grove
- UC San Diego Health System - La Jolla
- Gastro Care Institute - Lancaster
- Om Research LLC - Lancaster
- United Medical Doctors - Murrieta
- University of California, Davis - Sacramento
- University of California San Francisco - San Francisco
- Amicis Research Center - Valencia
Florida
- Luna Research - Coral Gables
- University of Florida - Gainesville
- The Medici Medical Research - Hollywood
- Encore Medical Research, LLC - Hollywood
- Clinical Research of Osceola - Kissimmee
- Florida Research Institute - Largo
- Wellness Research Center - Miami
- IMIC Inc - Miami
- Reserka LLC - Miami
Arizona
- GI Alliance - Sun City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2023-12-05 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
What NCT06029972 shows while recruiting
NCT06029972 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06029972 names 20 study sites across 3 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06029972 about?
NCT06029972 is a clinical study titled "Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis". 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 participant...
What is the current status of trial NCT06029972?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2023-12-05. Estimated completion is 2028-02.
What conditions does trial NCT06029972 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT06029972?
The interventions under investigation include: Placebo (DRUG), Tilpisertib Fosmecarbil (DRUG).
Who is sponsoring clinical trial NCT06029972?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06029972 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06029972's enrollment target sits among peer trials
176 47th of 122 higher than 76 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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