Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatments gs-5745, placebo
Phase phase 2
Target MMP-9
Sponsor Gilead Sciences
Start date April 2015
End date October 2016
Trial size 187 participants
Trial identifier NCT02405442, 2015-001249-10, GS-US-395-1663

Summary

This study will primarily evaluate the safety and efficacy of GS-5745 in adults with active Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by an Open Label Extension. Participants who complete the Blinded Treatment Period will be eligible to enroll in the optional Open Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with GS-5745 for an additional 156 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo weekly for 8 weeks
placebo
Placebo to match GS-5745 administered via subcutaneous (SC) injection
(Experimental)
GS-5745 150 mg alternating with placebo weekly for 8 weeks
gs-5745
GS-5745 administered via subcutaneous (SC) injection
placebo
Placebo to match GS-5745 administered via subcutaneous (SC) injection
(Experimental)
GS-5745 150 mg weekly for 8 weeks
gs-5745
GS-5745 administered via subcutaneous (SC) injection
(Experimental)
GS-5745 300 mg weekly for 8 weeks
gs-5745
GS-5745 administered via subcutaneous (SC) injection
(Experimental)
All enrolled participants will be eligible to enroll in the Open Label Extension to receive GS-5745 150 mg weekly for an additional 44 weeks.
gs-5745
GS-5745 administered via subcutaneous (SC) injection
(Experimental)
Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with GS-5745 for an additional 156 weeks.
gs-5745
GS-5745 administered via subcutaneous (SC) injection

Primary Outcomes

Measure
Proportion of participants achieving clinical response at Week 8
time frame: Week 8
Proportion of participants achieving endoscopic response at Week 8
time frame: Week 8

Secondary Outcomes

Measure
Proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission at Week 8
time frame: Week 8
Proportion of participants achieving mucosal healing at Week 8
time frame: Week 8

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Key Inclusion Criteria: - Ability to provide a written informed consent - Females of childbearing potential must have a negative pregnancy test at screening and baseline - Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum - Moderately to severely active Crohn's disease as defined by a CDAI total score between 220-450 (inclusive) AND with evidence of active disease as measured by ileocolonoscopy - Within the previous 5 years, demonstrated an inadequate clinical response or intolerance of at least one of the following agents: - Corticosteroids: - Immunomodulators: - tumor necrosis factor-alpha (TNFα) Antagonists: - Vedolizumab: - May be receiving the following drugs: - Oral 5-aminosalicylate (5-ASA) - Oral corticosteroid therapy - Antidiarrheals for chronic diarrhea - Azathioprine or 6-mercaptopurine (6-MP) or methotrexate - Antibiotics for the treatment of Crohn's Disease - Able to comply with the dosing instructions for study drug and able to comply with the study visits and requirements Key Exclusion Criteria: - Evidence of abscess at screening - Extensive colonic resection (subtotal or total colectomy) or history of > 2 small bowel resections - Ileostomy, colostomy, or symptomatic stenosis of the intestine - Current use of oral corticosteroids at a dose equivalent to > 30 mg/day of prednisone - Ulcerative colitis or indeterminate colitis - Short bowel syndrome - Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia - Treatment with any monoclonal antibody within 4 weeks of screening - History or evidence of colonic mucosal dysplasia - HIV, hepatitis B, hepatitis C, or tuberculosis (TB) infection - Participated in a clinical study with an investigational drug or biologic within the last 30 days - Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.