Phase 2 study of GS-5745 in Subjects with Crohn`s Disease
Research type
Research Study
Full title
A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease
IRAS ID
187388
Contact name
Satish Keshav
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2015-001249-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
Crohn`s disease (CD) is a chronic, relapsing and remitting inflammatory bowel disease with no medical or surgical cure. In up to 80% of patients major intestinal surgery is required. The treatment goal is to induce and maintain remission. Medical treatment includes corticosteroids, immunosuppressants such as Azathioprine, and biologic agents such as Infliximab, Adalimumab, and recently, Vedolizumab. In the most severely affected patients, even biologic agents achieve remission rates of approximately 20%. Furthermore, current treatments expose patients to the risk of infection, and in rare cases, malignancy. Therefore, there is an unmet need for safer and more effective therapies for moderately to severely active CD.
GS-5745 blocks the action of the protein MMP9, a protein digesting enzyme that may contribute to the pathology of CD. Therefore GS-5745 may be an alternative treatment option. The purpose of this study is to test its safety and efficacy in adults with moderate to severely active CD.
This is a randomised, double-blind, placebo-controlled study comprising an 8 week blinded induction treatment with the option for open-label treatment extension of 150mg weekly for an additional 44 weeks. The doses of GS-5745 will be 150mg every other week, 150mg weekly, or 300 mg weekly administered by subcutaneous injection. Subjects will be randomised in a ratio of 1:2:2:2 (placebo to each of three treatment regimens).
Study visits for all participants will occur at screening, Weeks 0 (baseline), 1, 3, 5, and 7 for the Blinded Induction Treatment followed by a Week 8 visit for an assessment of efficacy. GS-5745 may be administered at home by self-injection, or at the study site at Weeks 2, 4, and 6. Patients who complete the Week 8 assessment will be eligible to enter the Open Label Extension study.
The study will be run in approximately 90 sites globally and 175 subjects recruited.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0583
Date of REC Opinion
11 Dec 2015
REC opinion
Further Information Favourable Opinion