In short
Clinical trials are studying Gs-1427 in people with moderately to severely active ulcerative colitis. These trials are designed to check whether Gs-1427 can help improve symptoms and measure its safety and effectiveness compared with placebo.
Key points
- Clinical trials of Gs-1427 are studying people with moderately to severely active ulcerative colitis. The main trial is a Phase 2 study with 256 planned participants. It compares Gs-1427 with placebo control to see whether it can produce a clinical response by Week 12. The main outcome uses the modified Mayo Clinic Score and the rectal bleeding score. This research is focused on patients with active disease who may benefit from better symptom control.
Clinical trial overview
The available study of Gs-1427 is being done in people with moderately to severely active ulcerative colitis, which is a form of inflammatory bowel disease that affects the large intestine and rectum.
This is an interventional study, which means researchers give study treatment and then compare results across groups.
The study is in Phase 2, a stage that usually looks more closely at whether a treatment may work while continuing to collect safety information.
Who can join the study
The trial is designed for participants who have ulcerative colitis with moderate to severe activity.
This means the study is not for the general population, but for people whose disease is active enough to be measured in a clinical trial.
Study design and treatment groups
The study aims to assess the efficacy of Gs-1427 compared with placebo control.
A placebo is a look-alike treatment that does not contain the active study drug, and it helps researchers compare outcomes fairly.
The trial listing also includes PTM tablets at 25 mg, 75 mg, and 100 mg, along with Gs-1427 oral doses of 25 mg, 75 mg, and 100 mg.
What the trial measures
The main endpoint is clinical response at Week 12.
In this study, clinical response means a drop in the modified Mayo Clinic Score (mMCS) by at least 2 points and by at least 30% from baseline, plus improvement in the rectal bleeding score.
The rectal bleeding part of the score must improve by at least 1 point from baseline or reach an absolute score of 0 or 1.
These measurements help researchers see whether symptoms and disease activity are getting better over the 12-week study period.
Study status and size
The study is listed as Authorised, which means it has been approved to move forward.
The planned enrollment is 256 participants.
This size suggests the trial is large enough to look for early signs of benefit in ulcerative colitis while still being a mid-stage study.