Trial record 11 of 83 for:    gastroenterology | Recruiting | Exclude Unknown | United States

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02405442
First received: March 27, 2015
Last updated: July 13, 2016
Last verified: July 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving endoscopic response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving mucosal healing at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 175
Study Start Date: April 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: December 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)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  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

Contacts
Contact: Gilead Study Team 395-1663study@gilead.com

  Show 118 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Bittoo Kanwar, MD 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 
Study First Received: March 27, 2015
Last Updated: July 13, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on July 28, 2016