Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease

• Status: Terminated
• Trial end date: 2017-11-09
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once daily in patients with active Crohn's Disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

Criteria

Inclusion Criteria:

• Male or female ≥ 18 years of age.

• Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)

• Subject must have failed or experienced intolerance to at least one of the following:

budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

• Subject must use protocol approved contraception

Exclusion Criteria:

• Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis

• Crohn's Disease (CD) manifestations such as abscesses, short bowel syndrome; or intestinal strictures with prestenotic dilatation, requiring procedural intervention or not passable with an adult colonoscope.

• Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit

• Ileostomy or a colostomy

• Prior treatment with more than 2 TNF-α blockers (eg, infliximab or adalimumab).

• Prior treatment with any integrin antagonists (eg, natalizumab or vedolizumab).

• Subject is pregnant or breastfeeding.

• Subject has received prior treatment with mongersen (GED-0301), or participation in a clinical study involving mongersen (GED-0301).