Study of GS-1427
Study of GS-1427
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (SWIFT)
This is a phase 2 clinical trial designed to evaluate an investigational treatment, GS-1427, in adult patients diagnosed with moderate to severe ulcerative colitis. The study is conducted under a randomized, double-blind, placebo-controlled design, comparing the safety and efficacy of different doses of GS-1427 against a placebo group. The primary objective is to determine whether the investigational drug is effective in inducing clinical improvement in this population.
Popular Question
Patients must have a diagnosis of ulcerative colitis confirmed by endoscopy and histology, with the original documentation available. Symptoms must have been present for at least 90 days before entering the study.
The ulcerative colitis must extend at least 15 centimeters from the anal verge to participate in the study.
Participants must have active moderate to severe ulcerative colitis. This is determined by a screening endoscopy with a modified Mayo Clinic Score (mMCS) between 5 and 9, including an endoscopic sub-score of at least 2.
To be eligible, you must have had an inadequate response, a loss of response, or be intolerant to at least one of the following treatments: corticosteroids, immunomodulators, or advanced therapies.
Yes. You cannot have had an inadequate response or be intolerant to 3 or more different mechanisms of action of advanced therapies. Note: using multiple drugs with the same mechanism of action (e.g., two TNF-α inhibitors) counts as only one mechanism.
You would be excluded if you have Crohn’s disease, indeterminate colitis, toxic megacolon, symptomatic colonic stenosis, severe acute colitis, fulminant colitis, or an abdominal abscess at the time of screening.
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