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NCT Number: NCT06290934

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Macquarie University, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

emvistegrast

Drug

Administered orally

Other names: GS-1427

Placebo-to-match emvistegrast

Drug

Administered orally

Primary outcomes

  1. Proportion of Participants Achieving Clinical Response at Week 12

    Time frame: 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. The mMCS is a scoring system for assessment of Ulcerative Colitis (UC) activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

Secondary outcomes

  1. Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths.

    Time frame: First dose date up to 116 weeks plus 28 days

  2. Incidence of Treatment-emergent Lab Abnormalities

    Time frame: First dose date up to 116 weeks plus 28 days

  3. Proportion of Participants Achieving Clinical Remission at Week 12

    Time frame: Week 12

    Clinical remission is defined as a mMCS of ≤ 2, 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).The mMCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

  4. Proportion of Participants Achieving Clinical Remission at Week 52

    Time frame: Week 52

    Clinical remission is defined as a mMCS of ≤ 2, 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). The mMCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

  5. Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12

    Time frame: Week 12

    Histologic-endoscopic mucosal improvement is a composite endpoint that uses different units of measure for histologic and endoscopic activities.Histologic activity is measured by the Geboes score with 6 grades:0,structural change(sub-grade:0.0-0.3);1,chronic inflammatory infiltrate(sub-grade:1.0-1.3);2,lamina propria neutrophils & eosinophils(sub-grade:2A.0-2B.3);3,neutrophils in epithelium(sub-grade:3.0-3.3);4,crypt destruction(sub-grade:4.0-4.3); and 5,erosion or ulceration(sub-grade:5.0-5.4);final score range 0.0-5.4;higher scores indicate more severe inflammation.Endoscopic activity is measured by the Mayo Clinic Score Endoscopic subscores(range 0-3):0,normal or inactive disease;1,mild disease(erythema,decreased vascular pattern);2,moderate disease(marked erythema,lack of vascular pattern,friability,erosions), and 3,severe disease(spontaneous bleeding,ulceration).Histologic-endoscopic mucosal improvement is defined as achieving both Geboes score ≤ 3.1 and endoscopic subscore ≤ 1

  6. Proportion of Participants Achieving Mucosal Healing at Week 12

    Time frame: Week 12

    Mucosal healing is a composite endpoint that uses different units of measure for histologic and endoscopic activities. Histologic activity is measured by the Geboes score with 6 grades:0,structural change(sub-grade:0.0-0.3);1,chronic inflammatory infiltrate(sub-grade:1.0-1.3);2,lamina propria neutrophils & eosinophils(sub-grade:2A.0-2B.3);3,neutrophils in epithelium(sub-grade:3.0-3.3);4,crypt destruction(sub-grade:4.0-4.3); and 5,erosion or ulceration(sub-grade:5.0-5.4);final score range 0.0-5.4;higher scores indicate more severe inflammation.Endoscopic activity is measured by the Mayo Clinic Score Endoscopic subscores(range 0-3):0,normal or inactive disease;1,mild disease(erythema,decreased vascular pattern);2,moderate disease(marked erythema,lack of vascular pattern,friability,erosions), and 3,severe disease(spontaneous bleeding,ulceration).Mucosal healing is defined as achieving both Geboes score ≤ 2B.1 and endoscopic subscore ≤ 1.

  7. Proportion of Participants Achieving Endoscopic Improvement at Week 12

    Time frame: Week 12

    Endoscopic improvement is defined as an endoscopic subscore of ≤ 1. Endoscopic subscore is a part of the modified Mayo Clinic Score which is a scoring system for assessment of UC activity. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration).

  8. To Assess the Efficacy of Emvistegrast in Achieving Partial Modified Mayo Clinic Score (mMCS) remission at Week 52

    Time frame: Week 52

    Partial mMCS remission is defined as a SFS ≤ 1 and rectal bleeding subscore of 0.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Acronym: SWIFT

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 4, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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