← Back to Search

Monoclonal Antibodies

Part 1A, Part 1B: GS-1427 Dose C 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 first dose date up to 52 weeks plus 28 days

Awards & highlights

SWIFT Trial 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.Check my eligibility

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.See study design

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.

SWIFT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date up to 52 weeks plus 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date up to 52 weeks plus 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to 52 weeks plus 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

+10 more

SWIFT 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

2013

Completed Phase 4

~4140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

847,839 Total Patients Enrolled

7 Trials studying Ulcerative Colitis

2,986 Patients Enrolled for Ulcerative Colitis

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,270 Total Patients Enrolled

6 Trials studying Ulcerative Colitis

2,958 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for participation in this medical study inclusive of individuals who are 65 years or older?

"Eligible participants must be over 18 years old but under the age of 75 to enroll in this study."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, details on clinicaltrials.gov highlight that this research endeavor is presently enrolling participants. Commencing its public posting on March 27th, 2024, the trial's most recent update was recorded on April 1st of the same year. In total, 423 individuals will be enlisted across six distinct locations for this study."

Answered by AI

What is the current number of participants being enrolled in this research project?

"The inclusion criteria mandate the participation of 423 eligible patients in this clinical investigation. Patients have the opportunity to enroll at various sites, including Encore Medical Research, LLC situated in Hollywood, Florida and Quality Medical Research located in Nashville, Tennessee."

Answered by AI

At how many distinct locations is this medical trial being administered?

"Patients are being recruited at Encore Medical Research. LLC situated in Hollywood, Florida, Quality Medical Research based in Nashville, Tennessee, and Encore Medical Research of Weston, LLC located in Weston, Michigan along with 6 additional sites."

Answered by AI

What is the level of risk associated with Part 1A, Part 1B: GS-1427 Dose C for individuals?

"Our team at Power has evaluated the safety of Part 1A, Part 1B: GS-1427 Dose C to be a level 2 on our scale. This decision is based on the fact that this trial falls under Phase 2, indicating existing data supporting safety but lacking evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06290934.

All > Pflugerville Tx > Paid Studies Pasadena