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Gs-1427

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.

Table of Contents

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.[1]

This is an interventional study, which means researchers give study treatment and then compare results across groups.[1]

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.[1]

Who can join the study

The trial is designed for participants who have ulcerative colitis with moderate to severe activity.[1]

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.[1]

Study design and treatment groups

The study aims to assess the efficacy of Gs-1427 compared with placebo control.[1]

A placebo is a look-alike treatment that does not contain the active study drug, and it helps researchers compare outcomes fairly.[1]

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.[1]

What the trial measures

The main endpoint is clinical response at Week 12.[1]

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.[1]

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.[1]

These measurements help researchers see whether symptoms and disease activity are getting better over the 12-week study period.[1]

Study status and size

The study is listed as Authorised, which means it has been approved to move forward.[1]

The planned enrollment is 256 participants.[1]

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.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT06290934Phase 2Ulcerative colitisAuthorised256

FAQ

  • What is being studied in Gs-1427 trials? The trials are studying Gs-1427 in people with ulcerative colitis. The main goal is to see whether it can improve disease signs by Week 12.
  • Who can take part in these trials? The trial is for participants with moderately to severely active ulcerative colitis. This means people must have a certain level of active disease to join.
  • What phase is the Gs-1427 study? The study is a Phase 2 trial. Phase 2 trials usually look more closely at whether a treatment works and continue to watch safety.
  • What is the main result the trial measures? The main result is clinical response at Week 12. This is measured by changes in the modified Mayo Clinic Score and the rectal bleeding score.
  • Is Gs-1427 being compared with anything else? Yes. The study compares Gs-1427 with placebo control. A placebo looks like treatment but does not have the active study drug.

Ongoing Clinical Trials on Gs-1427

  • Study on GS-1427 for Adults with Moderate to Severe Ulcerative Colitis

    Not recruiting

    2 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Hungary +4

Glossary

  • Ulcerative colitis (UC): A long-term disease that causes swelling and sores in the large intestine and rectum. It can lead to diarrhea, bleeding, and belly pain.
  • Moderately to severely active: A description of how strong the disease is. It means the symptoms and inflammation are significant enough to need careful study.
  • Phase 2: A mid-stage clinical trial. It usually checks whether a treatment may work and continues to collect safety information.
  • Interventional study: A study where researchers give a treatment or placebo and then measure the results.
  • Placebo: A look-alike treatment that does not contain the active study drug. It helps researchers compare results fairly.
  • Clinical response: An improvement in the disease based on set score changes used by the trial.
  • Modified Mayo Clinic Score (mMCS): A scoring system used in ulcerative colitis trials to measure disease activity. Lower scores usually mean less active disease.
  • Rectal bleeding subscore: A part of the trial score that measures bleeding from the rectum. It helps show whether symptoms are improving.
  • Week 12: The time point 12 weeks after the study starts. The main outcome in this trial is checked at that time.
  • Enrollment: The number of people planned or included in the study.

References