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NCT06290934Not yet recruiting

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-blind, 2-Part Phase 2 Study to Evaluate the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) Part 1: Placebo-Controlled, Dose-Ranging Study of GS-1427; Part 2: Active-Controlled, Combination Study Evaluating the Efficacy and Safety of GS-1427 in Combination With Ustekinumab Versus GS-1427 or Ustekinumab Monotherapy
Gilead SciencesPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
GS-1427
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Gilead Sciences
Timeline & enrollment
Phase
Phase 2
Start date
Mar 01, 2024
End date
Mar 01, 2028
Enrollment
423 participants
Primary outcome

Parts 1 and 2: Proportion of Participants Achieving Clinical Response at Week 12

Summary

The goal of this study is to learn if GS-1427 is effective and safe in treating participants
 with moderate to severe ulcerative colitis. The study will compare participants in different
 treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and
 participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427
 in combination with ustekinumab (Part 2).
 
 The primary objectives of this study are:
 
 Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving
 clinical response at Week 12
 
 Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared
 with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06290934
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06290934 through Pure Global AI's free database. This Phase 2 trial is sponsored by Gilead Sciences and is currently Not yet recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 423 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.