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Evaluating GS-1427 for treating moderate to severe ulcerative colitis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Phase 2 Interventional Gilead Sciences · NCT06290934

This study is testing a new medication called GS-1427 to see if it can help people with moderate to severe ulcerative colitis who haven't found relief with other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment228 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorGilead Sciences Industry-sponsored
Drugs / interventionsvedolizumab
Locations150 sites (Peoria, Arizona and 149 other locations)
Trial IDNCT06290934 on ClinicalTrials.gov

What this trial studies

This study aims to determine the effectiveness of GS-1427 in participants suffering from moderately to severely active ulcerative colitis. Participants will be divided into groups receiving either GS-1427 or a placebo, with the primary goal of assessing clinical response at Week 12. The study will include individuals who have had a confirmed diagnosis of ulcerative colitis for at least 90 days and have not adequately responded to previous treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderately to severely active ulcerative colitis who have had inadequate responses to previous treatments.

Not a fit: Patients with mild ulcerative colitis or those who have not tried any prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with moderate to severe ulcerative colitis who have not responded to existing therapies.

How similar studies have performed: Other studies have shown promise in treating ulcerative colitis with novel therapies, but the specific approach of GS-1427 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents.
* Individuals have UC with minimum disease extent of 15 cm from the anal verge.
* Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
* Individuals have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: corticosteroids, immunomodulators, or advanced therapy.
* Individuals have an inadequate response or loss of response or are intolerant to \< 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action)

Key Exclusion Criteria:

* Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies such as an enteric pathogen, or lymphocytic or collagenous colitis.
* Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.
* Have any history of exposure to vedolizumab or other integrin antagonists
* Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Where this trial is running

Peoria, Arizona and 149 other locations

+100 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.