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Monoclonal Antibodies

GS-1427 for Ulcerative Colitis (SWIFT Trial)

Phase 2

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Summary

"This trial is testing a new drug, GS-1427, to see if it is safe and effective in treating people with moderate to severe ulcerative colitis. The study will compare different groups of

Who is the study for?

This trial is for individuals who have had Ulcerative Colitis for at least 90 days, confirmed by previous tests. They should have moderate to severe symptoms and not responded well or tolerated at least one standard treatment like corticosteroids or azathioprine.

What is being tested?

The study tests if GS-1427 can effectively treat Ulcerative Colitis compared to a placebo. It also compares the effectiveness of combining GS-1427 with ustekinumab versus using each drug alone in achieving a clinical response after 12 weeks.

What are the potential side effects?

Potential side effects may include typical reactions associated with immune-modulating drugs such as injection site reactions, increased risk of infections, possible liver issues, and flu-like symptoms among others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Parts 1 and 2: Proportion of Participants Achieving Clinical Response at Week 12

Secondary study objectives

Part 1: Proportion of Participants Achieving Clinical Remission at Week 52

Part 2: Proportion of Participants Achieving Clinical Remission at Week 24

Part 2: Proportion of Participants Achieving Clinical Response at Week 24

+8 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part 2: Ustekinumab MonotherapyExperimental Treatment1 Intervention

Participants will receive ustekinumab, initial dose determined by body weight: 260 to 520 mg intravenous (IV), then subsequent dose: 90 mg subcutaneous (SC) 8 weeks after the initial IV dose, and every 8 weeks up to week 16 ( total of 2 subcutaneous injections after initial IV ustekinumab). Participants will be eligible to continue and remain on the ustekinumab through Week 24.

Group II: Part 2: Open-label GS-1427Experimental Treatment1 Intervention

Participants who complete Part 2 Week 24, will be eligible to continue and and receive open-label GS-1427 through Week 52 at a dose to be determined in Part 1A.

Group III: Part 2: GS-1427 MonotherapyExperimental Treatment1 Intervention

Participants will receive GS-1427 (at a dose determined based in Part 1A) Day 1 through Week 12. Participants will be eligible to continue and remain on the same dose of GS-1427 through Week 24.

Group IV: Part 2: GS-1427 + Ustekinumab Combination TherapyExperimental Treatment2 Interventions

Participants will receive GS-1427 (dose determined based on Part 1A) and ustekinumab, initial dose determined by body weight: 260 to 520 mg IV, then subsequent dose: 90 mg SC 8 weeks after the initial IV dose, and every 8 weeks up to week 16 ( total of 2 subcutaneous injections after initial IV ustekinumab). Participants will be eligible to continue and remain on the same dose of GS-1427 and ustekinumab combination therapy through Week 24.

Group V: Part 1A, Placebo; Part 1B, GS-1427Experimental Treatment2 Interventions

Participants will receive Placebo to match GS-1427 Day 1 through Week 12 (Part 1A). Participants will be eligible to be re-randomized to receive one of the GS-1427 dose A, B, or C treatment after Week 12 through Week 52 (Part 1B).

Group VI: Part 1A, Part 1B: GS-1427 Dose CExperimental Treatment1 Intervention

Participants will receive GS-1427 Dose C Day 1 through Week 12 (Part 1A). Participants will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part 1B).

Group VII: Part 1A, Part 1B: GS-1427 Dose BExperimental Treatment1 Intervention

Participants will receive GS-1427 Dose B Day 1 through Week 12 (Part 1A). Participants will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part 1B).

Group VIII: Part 1A, Part 1B: GS-1427 Dose AExperimental Treatment1 Intervention

Participants will receive GS-1427 Dose A Day 1 through Week 12 (Part 1A). Participants will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part 1B).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2015

Completed Phase 4

~4080

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