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Study of GS-1427 in Participants With Moderately to Severely Active UC
EU CTIS ID: 2023-508304-38-00
What this study is testing
To assess the efficacy of GS 1427, compared with placebo control, in achieving clinical response at Week 12
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants have UC with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents.
- Participants have UC with minimum disease extent of 15 cm from the anal verge.
- Participants have moderately to severely active UC as determined by endoscopy occurring during screening with a total mMCS of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
- Participants have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: Corticosteroids Immunomodulators: azathioprine, 6-mercaptopurine, or 6-thioguanine (see full inclusion criteria for details) Advanced therapy: have an inadequate response or loss of response or are intolerant to an advanced therapy (AT) for the treatment of UC: ○ Tumor necrosis factor-alpha (TNF-α) inhibitor: eg, infliximab, adalimumab, golimumab, or biosimilars ○ Interleukin-12/23 inhibitor: eg, Ustekinumab. Sphingosine 1-phosphate receptor modulator: eg, ozanimod ○ Janus kinase inhibitor: eg, tofacitinib, upadacitinib, filgotinib
- Participants have an inadequate response or loss of response or are intolerant to < 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action):
You likely can't join if
- Have a current diagnosis of Crohn’s disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to causes such as an enteric pathogen, or lymphocytic or collagenous colitis.
- Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.
- Have any history of exposure to vedolizumab or other integrin antagonists.
- Have any history of stroke, seizure disorder, multiple sclerosis, neurodegenerative disease of brain (such as Parkinson’s disease, dementias), or brain tumor.
- Have a positive progressive multifocal leukoencephalopathy subjective checklist at screening or at randomization prior to the administration of the first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
- Georgia
- Korea, Republic of
- Moldova, Republic of
- Taiwan
- Hong Kong
- Australia
- Switzerland
- Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom; Georgia; Korea, Republic of; Moldova, Republic of and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.