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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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Participants Achieving Clinical Response at Week 12
Secondary study objectives
Proportion of Participants Achieving Clinical Remission at Week 12
Proportion of Participants Achieving Clinical Remission at Week 52
Proportion of Participants Achieving Endoscopic Improvement at Week 12
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part A, Placebo; Part B, Part C: GS-1427Experimental Treatment2 Interventions
Participants will receive Placebo to match GS-1427 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 GS-1427 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 24 weeks (through Week 76).
Group II: Part A, Part B, Part C: GS-1427 Dose CExperimental Treatment1 Intervention
Participants will receive GS-1427 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 GS-1427 through Week 52 (Part B).
Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 24 weeks (through Week 76).
Group III: Part A, Part B, Part C: GS-1427 Dose BExperimental Treatment1 Intervention
Participants will receive GS-1427 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 GS-1427 through Week 52 (Part B).
Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 24 weeks (through Week 76).
Group IV: Part A, Part B, Part C: GS-1427 Dose AExperimental Treatment1 Intervention
Participants will receive GS-1427 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 GS-1427 through Week 52 (Part B).
Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 24 weeks (through Week 76).
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,137 Previous Clinical Trials
867,755 Total Patients Enrolled
7 Trials studying Colitis
2,986 Patients Enrolled for Colitis
Gilead Study DirectorStudy DirectorGilead Sciences
361 Previous Clinical Trials
192,125 Total Patients Enrolled
6 Trials studying Colitis
2,958 Patients Enrolled for Colitis