Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (SWIFT)

Gilead Sciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo-to-match emvistegrast; Drug: emvistegrast

Study type: Interventional

Funder types: Industry

Identifiers

NCT06290934

2023-508304-38 (Other Identifier)

GS-US-409-5704

Details and patient eligibility

About

The goal of this study is to learn if emvistegrast (formerly GS-1427) is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with emvistegrast with participants treated with placebo.

The primary objective of this study is to assess the efficacy of emvistegrast, compared with placebo control, in achieving clinical response at Week 12.

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Individuals have Ulcerative Colitis (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.
• Individuals have UC with minimum disease extent of 15 cm from the anal verge.
• Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
• Individuals have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: corticosteroids, immunomodulators, or advanced therapy.
• Individuals 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)

Key Exclusion Criteria:

• Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies 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
• Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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228 participants in 4 patient groups

Part A, Part B, Part C: Emvistegrast Dose A

Experimental group

Description:

Participants will receive emvistegrast Dose A Day 1 through Week 12 (Part A). Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 64 weeks (through Week 116).

Treatment:

Drug: emvistegrast

Part A, Part B, Part C: Emvistegrast Dose B

Experimental group

Description:

Participants will receive emvistegrast Dose B Day 1 through Week 12 (Part A). Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 64 weeks (through Week 116).

Treatment:

Drug: emvistegrast

Part A, Part B, Part C: Emvistegrast Dose C

Experimental group

Description:

Participants will receive emvistegrast Dose C Day 1 through Week 12 (Part A). Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 64 weeks (through Week 116).

Treatment:

Drug: emvistegrast

Part A, Placebo; Part B, Part C: Emvistegrast

Experimental group

Description:

Participants will receive Placebo to match emvistegrast Day 1 through Week 12 (Part A). Part A placebo participants will be eligible to undergo re-randomization in a double-blind manner after endoscopy assessment at Week 12 to receive one of the emvistegrast dose A, B, or C treatments. Participants will be eligible to continue and remain on the new dose through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 64 weeks (through Week 116).

Treatment:

Drug: emvistegrast

Drug: Placebo-to-match emvistegrast