Study of GS-1427 in Participants With Moderately to Severely Active UC

Phase 2

Recruiting

• Conditions: Ulcerative Colitis (UC)

• Registration Number: 2023-508304-38-00
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

To assess the efficacy of GS 1427, compared with placebo control, in achieving clinical response at Week 12

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-04
• Study Start: 2024-03-27
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-07
• Primary Completion: 2025-10
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

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 (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: 1)Tumor necrosis factor-alpha (TNF-α) inhibitor: eg, infliximab, adalimumab, golimumab, or biosimilars 2)Interleukin-12/23 inhibitor: eg, ustekinumab 3)Sphingosine 1-phosphate receptor modulator: eg, ozanimod 4) Janus Kinase inhibitor: eg, tofacitinib, upadacitinib, filgotinibkinas

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):

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Clinical response at Week 12 Clinical response is defined as a decrease from baseline in the modified Mayo Clinic Score (mMCS) of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥ 1 from baseline or an absolute rectal bleeding subscore of 0 or 1.		Clinical response at Week 12 Clinical response is defined as a decrease from baseline in the modified Mayo Clinic Score (mMCS) of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥ 1 from baseline or an absolute rectal bleeding subscore of 0 or 1.

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events, serious adverse events, or deaths, and treatment-emergent laboratory abnormalities		Incidence of treatment-emergent adverse events, serious adverse events, or deaths, and treatment-emergent laboratory abnormalities
Clinical remission at Week 12		Clinical remission at Week 12
Clinical remission at Week 52 Clinical remission is defined as an mMCS of ≤ 2 points, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally-read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability).		Clinical remission at Week 52 Clinical remission is defined as an mMCS of ≤ 2 points, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally-read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability).
Histologic-endoscopic mucosal improvement at Week 12 Histologic-endoscopic mucosal improvement is defined as a Geboes score ≤ 3.1 and endoscopic subscore of ≤ 1.		Histologic-endoscopic mucosal improvement at Week 12 Histologic-endoscopic mucosal improvement is defined as a Geboes score ≤ 3.1 and endoscopic subscore of ≤ 1.
Mucosal healing at Week 12 Mucosal healing is defined as a Geboes score ≤ 2B.1 and endoscopic subscore ≤ 1.		Mucosal healing at Week 12 Mucosal healing is defined as a Geboes score ≤ 2B.1 and endoscopic subscore ≤ 1.
Endoscopic improvement at Week 12 Endoscopic improvement is defined as an endoscopic subscore ≤ 1.		Endoscopic improvement at Week 12 Endoscopic improvement is defined as an endoscopic subscore ≤ 1.
Partial mMCS remission at Week 76 Partial mMCS remission is defined as a SFS ≤ 1 and rectal bleeding subscore of 0.		Partial mMCS remission at Week 76 Partial mMCS remission is defined as a SFS ≤ 1 and rectal bleeding subscore of 0.

Trial Locations

Locations (183)

Onyx Clinical Research (Clinic Location); 🇺🇸 Peoria, Arizona, United States

Om Research LLC; 🇺🇸 Lancaster, California, United States

VVCRD Research; 🇺🇸 Garden Grove, California, United States

310 Clinical Research; 🇺🇸 Inglewood, California, United States

US San Diego Health System; 🇺🇸 La Jolla, California, United States

United Medical Doctors; 🇺🇸 Murrieta, California, United States

UCSF Benioff Children's Hospital Oakland; 🇺🇸 Oakland, California, United States

University Of California, Davis; 🇺🇸 Sacramento, California, United States

SDG Clinical Research, LLC; 🇺🇸 San Diego, California, United States

Acclaim Clinical Research; 🇺🇸 San Diego, California, United States

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