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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Suryakanth Gurudu, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
.

Mayo Clinic Footer