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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

Keywords

Crohn Disease Crohn's Disease GED-0301 Mongersen IBD Safety Efficacy

Eligibility

You can join if…

Open to people ages 18 years and up

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 CAN'T join 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.

Locations

  • High Desert Gastroenterology, Inc. accepting new patients
    Lancaster, California, 93534, United States
  • Ventura Clinical Trials accepting new patients
    Ventura, California, 93003, United States
  • Facey Medical Foundation accepting new patients
    Mission Hills, California, 91345, United States
  • T. Joseph Raoof MD Inc accepting new patients
    Encino, California, 91436, United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • University of Southern California Medical Center accepting new patients
    Los Angeles, California, 90032, United States
  • HCP Clinical Research LLC accepting new patients
    Anaheim, California, 92801, United States
  • Valley View Internal Medicine accepting new patients
    Garden Grove, California, 92843, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02596893
Phase
Phase 3
Lead Scientist
Jonathan Terdiman
Study Type
Interventional
Last Updated
August 1, 2017
I’m interested in this study!