A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone. All patients who complete the study will have the option to enter a long term active treatment study.

Key facts

Study ID

NCT02974322

Run by

Celgene

People needed

0

Starts

2017-12-01

Expected to finish

2018-12-24

Last updated by the study team

2017-11-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must satisfy the following criteria to be enrolled in the study:
• Male or female ≥ 12 years
• Subject is able to swallow the IP tablets
• 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)
• Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7day period
• 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 (ie, infliximab, adalimumab, certolizumab, or vedolizumab).

You may not qualify if…

• The presence of any of the following will exclude a subject from enrollment: Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis, or colitis due to immunodeficiency
• Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
• Subject has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
• Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
• Ileostomy or a colostomy
• Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study
• Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until the Week 12 visit.

Where it is running

• Arizona Digestive Health — Mesa, Arizona, United States
• Arizona Digestive Health — Phoenix, Arizona, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Arizona Digestive Health — Sun City, Arizona, United States
• Gastroenterology Associates PA — Little Rock, Arkansas, United States
• Valley View Internal Medicine — Garden Grove, California, United States
• High Desert Gastroenterology, Inc. — Lancaster, California, United States
• University of Southern California Medical Center — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Medical Associates Research Group Inc. — San Diego, California, United States
• University of California at San Francisco (PARENT) — San Francisco, California, United States
• HCP Clinical Research LLC — Torrance, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• University Of Colorado — Aurora, Colorado, United States
• Innovative Clinical Research — Lafayette, Colorado, United States
• Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
• Medical Research Center of Connecticut LLC — Hamden, Connecticut, United States
• Connecticut GI PC Research Division — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• University of Miami — Miami, Florida, United States
• Dcr-Pi Pc — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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