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Safety and Efficacy of GS-5745 in Participants With Moderately to Severely Active Crohn's Disease

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02405442
First received: March 27, 2015
Last updated: February 23, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Crohn's Disease
Drug: GS-5745
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 187
Study Start Date: April 2015
Study Completion Date: December 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group A (Blinded Treatment)
Placebo weekly for 8 weeks
Drug: Placebo
Placebo to match GS-5745 administered via subcutaneous (SC) injection
Experimental: Group B (Blinded Treatment)
GS-5745 150 mg alternating with placebo weekly for 8 weeks
Drug: GS-5745
GS-5745 administered via subcutaneous (SC) injection
Drug: Placebo
Placebo to match GS-5745 administered via subcutaneous (SC) injection
Experimental: Group C (Blinded Treatment)
GS-5745 150 mg weekly for 8 weeks
Drug: GS-5745
GS-5745 administered via subcutaneous (SC) injection
Experimental: Group D (Blinded Treatment)
GS-5745 300 mg weekly for 8 weeks
Drug: GS-5745
GS-5745 administered via subcutaneous (SC) injection
Experimental: Open Label Extension GS-5745
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.
Drug: GS-5745
GS-5745 administered via subcutaneous (SC) injection
Experimental: Extended Treatment Phase GS-5745
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.
Drug: GS-5745
GS-5745 administered via subcutaneous (SC) injection

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02405442

  Show 74 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Team Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02405442     History of Changes
Other Study ID Numbers: GS-US-395-1663
2015-001249-10 ( EudraCT Number )
Study First Received: March 27, 2015
Last Updated: February 23, 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on March 22, 2017