Pure Global

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis - Trial NCT06290934

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06290934
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06290934
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Ulcerative Colitis

GS-1427

Interventional

drug

Sponsor & Location

Gilead Sciences

Timeline & Enrollment

Phase 2

Mar 01, 2024

Mar 01, 2028

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 colitis
Other ulcerative colitis
Ulcerative colitis, unspecified
Arthropathy in ulcerative colitis
Juvenile arthritis in ulcerative colitis

Data Source

ClinicalTrials.gov

NCT06290934

Non-Device Trial