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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 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. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

Key facts

Study ID

NCT02596893

Run by

Celgene

People needed

701

Starts

2015-12-08

Expected to finish

2018-01-05

Last updated by the study team

2019-08-28

Who can join

Age: 18 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 ≥ 18 years
• 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 7 day 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.

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
• Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
• 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.

Where it is running

• Arizona Digestive Health — Mesa, Arizona, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Colon & Digestive Health Specialists — Scottsdale, Arizona, United States
• Arizona Digestive Health — Sun City, Arizona, United States
• Gastroenterology Associates PA — Little Rock, Arkansas, United States
• HCP Clinical Research LLC — Anaheim, California, United States
• T. Joseph Raoof MD Inc — Encino, California, United States
• Valley View Internal Medicine — Garden Grove, California, United States
• OM Research — 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
• Clinical Applications Laboratories Inc — San Diego, California, United States
• University of California at San Francisco — San Francisco, 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
• Florida Medical Research - Southeastern Integrated Medical — Gainesville, Florida, United States
• Sarkis Clinical Trials - Parent — Gainesville, Florida, United States
• ADDC Research LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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