GS-1427 for Ulcerative Colitis
(SWIFT Trial)
Recruiting in Palo Alto (17 mi)
+132 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Gilead Sciences
Must not be taking: Vedolizumab, Integrin antagonists
Disqualifiers: Crohn's disease, Toxic megacolon, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The goal of this study is to learn if GS-1427 is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo. The primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions that ongoing therapy with certain prohibited medications is not allowed. It's best to discuss your current medications with the trial team to see if they are permitted.
What data supports the effectiveness of the drug GS-1427 for treating ulcerative colitis?
Ustekinumab, a component of the treatment, has been shown to help some patients with ulcerative colitis achieve remission, meaning their symptoms improve significantly. In one case, a patient with severe ulcerative colitis who did not respond to other treatments experienced complete remission for over a year after using ustekinumab.12345
Is ustekinumab safe for humans?
How is the drug GS-1427 (Ustekinumab) different from other treatments for ulcerative colitis?
GS-1427, also known as Ustekinumab, is unique because it targets specific proteins (interleukins 12 and 23) involved in inflammation, offering a different approach compared to other treatments that may target different pathways. It is used for patients who have not responded well to conventional therapies, providing an alternative option for those with moderate-to-severe ulcerative colitis.14101112
Eligibility Criteria
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.Inclusion Criteria
I have had Ulcerative Colitis for at least 3 months, confirmed by tests.
My ulcerative colitis affects at least 15 cm of my colon.
My ulcerative colitis is active, with a Mayo Clinic Score of 5-9 and an endoscopy score of at least 2.
See 1 more
Exclusion Criteria
I have been diagnosed with Crohn's Disease or have symptoms that suggest it.
I currently have a severe colon condition such as toxic megacolon or an abdominal abscess.
I have been exposed to vedolizumab.
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part A
Participants receive GS-1427 or placebo from Day 1 through Week 12
12 weeks
Treatment Part B
Participants who complete Part A continue on the same dose of GS-1427 through Week 52
40 weeks
Treatment Part C
Participants who complete Part B continue onto a blinded treatment extension for an additional 24 weeks
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- GS-1427 (Monoclonal Antibodies)
- Ustekinumab (Monoclonal Antibodies)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Quality Medical ResearchNashville, TN
Clinical Associates in Research Therapeutics of America, LLCSan Antonio, TX
Om Research LLCLancaster, CA
Southwest Clinical TrialsHouston, TX
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Gilead SciencesLead Sponsor
References
Baseline peripheral blood mononuclear cell (PBMC) transcriptomics before ustekinumab treatment is linked with Crohn Disease clinical response at 1 year. [2023]Ustekinumab (Stelara), a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23, is used for Crohn Disease (CD), and the documented clinical remission rate after one year was observed in about 50% of patients. We aimed to identify predictors for a clinical response using peripheral blood obtained from CD patients just before ustekinumab treatment initiation.
Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI). [2021]We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).
Rapid Induction and Maintenance of Remission in Refractory Ulcerative Colitis with Ustekinumab. [2020]Ulcerative colitis is a chronic debilitating disease characterized by relapsing in intestinal inflammation and ulcers with no available cure. This is a clinical case report of a 52-year-old female patient with 30 years history of left-sided chronic ulcerative colitis controlled with standard of care (mesalamine and azathioprine) which subsequently relapsed and developed into active refractory ulcerative colitis. The patient became unresponsive to her medications including different forms of mesalamines and did not respond favorably to any of the other current therapies. Numerous attempts to stabilize her condition with immunosuppressants, steroids, probiotics, antibiotics, mesalamines, and various biologic agents failed to improve her clinical symptoms, and the patient was being considered for colectomy. As the last resort, modified therapy was prescribed with ustekinumab, a non-selective, anti-IL12/23 p40 monoclonal antibody. This medication has not been yet approved for use in ulcerative colitis patients. In this clinical case we report the efficacy of ustekinumab to rapidly induce and maintain remission of the severe chronic ulcerative colitis in the patient. To the best of our knowledge, this is the first report of utilizing ustakinamub therapy for rapid induction in an active refractory ulcerative colitis patient resulting in complete remission for over one year.
Extrapolating Pharmacodynamic Effects From Adults to Pediatrics: A Case Study of Ustekinumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis. [2021]Ustekinumab (STELARA) is a human monoclonal antibody against interleukins-12 and -23 for the treatment of adult and adolescent (≥ 12 to
A critical review of ustekinumab for the treatment of active ulcerative colitis in adults. [2023]Ustekinumab is a humanized monoclonal antibody, targeting the p40 subunit common to both human interleukin 12 and 23, approved by the European Medicines Agency and US Food and Drug Administration for the treatment of moderate-to-severe ulcerative colitis.
Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study. [2021]Phase III trials have demonstrated the efficacy and safety of ustekinumab in ulcerative colitis (UC), but few real-life long-term data are currently available.
Ustekinumab as induction and maintenance therapy for ulcerative colitis - national extended follow-up and a review of the literature. [2023]Ustekinumab use in ulcerative colitis had shown low adverse event and high persistence rates to 3 years via the UNIFI long-term extension study. Outcomes beyond 3 years have not been previously described. We describe the safety signals of the entire UNIFI Australian population beyond 3 years.
Ustekinumab for the treatment of moderate to severe ulcerative colitis: a multicentre UK cohort study. [2023]Ustekinumab is an interleukin-12/interleukin-23 receptor antagonist licensed for the treatment of ulcerative colitis (UC). Clinical trial data were promising; however, real-world data are limited. We assessed the safety and effectiveness of ustekinumab in UC in a real-world setting.
Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real-world cohort study. [2020]Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but few real-world data are currently available.
Long-term safety of ustekinumab for psoriasis. [2015]The biologic, Ustekinumab (Stelara®, Centocor, Inc., Malvern, PA, USA), is a fully human monoclonal antibody with a high affinity for the shared p40 subunit of interleukins 12 and 23 (IL-12 and IL-23). Approved for use in treating moderate-to-severe psoriasis in 2009, there has been considerable interest in the long-term safety of ustekinumab.
Ustekinumab: A Review in Moderate to Severe Crohn's Disease. [2018]Ustekinumab (Stelara®) has been recently approved in the EU and the USA as intravenous induction and subcutaneous maintenance therapy for adult patients with moderately to severely active Crohn's disease who have failed or were intolerant to treatment with immunomodulators, corticosteroids or at least one tumour necrosis factor (TNF) antagonist. Ustekinumab, a monoclonal antibody to the shared p40 subunit of the proinflammatory interleukin (IL)-12 and IL-23 cytokines, has a unique mechanism of action distinct from that of TNF antagonists. In pivotal phase III trials, compared with placebo, ustekinumab induction therapy improved clinical response and remission rates in patients who had previously failed or were intolerant to conventional therapies or at least one TNF antagonist. When administered as subcutaneous maintenance therapy, ustekinumab continued to offer benefits over placebo for clinical response and remission in patients who had clinically responded to the induction therapy. Ustekinumab was generally well tolerated as both induction and maintenance therapy; serious infections and malignancies were rare. Thus, ustekinumab presents a promising alternative treatment option in patients with moderately to severely active Crohn's disease who have failed or are intolerant to treatment with conventional therapies or TNF antagonists.
Safety evaluation of ustekinumab for moderate-to-severe ulcerative colitis. [2022]Ustekinumab is a human IgG1 kappa monoclonal antibody that targets the p40 subunit of interleukin (IL)-12 and IL-23 and blocks the binding of these cytokines to the IL-12Rβ1 chain of their receptors. Ustekinumab is approved for treating moderate-to-severe ulcerative colitis (UC).