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Summary

for people ages 12 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 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.

Official Title

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

Keywords

Crohn Disease Crohn's Disease GED-0301 Mongersen Adolescent Pediatric Children

Eligibility

You can join if…

Open to people ages 12 years and up

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 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, 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.

Locations

  • University of California at San Francisco (PARENT) not yet accepting patients
    San Francisco, California, 94115, United States
  • High Desert Gastroenterology, Inc. not yet accepting patients
    Lancaster, California, 93534, United States
  • Ventura Clinical Trials not yet accepting patients
    Ventura, California, 93003, United States
  • Facey Medical Foundation not yet accepting patients
    Mission Hills, California, 91345, United States
  • Childrens Hospital Los Angeles RHU not yet accepting patients
    Los Angeles, California, 90027-6062, United States
  • Cedars Sinai Medical Center not yet accepting patients
    Los Angeles, California, 90048, United States
  • University of Southern California Medical Center not yet accepting patients
    Los Angeles, California, 90032, United States
  • HCP Clinical Research LLC not yet accepting patients
    Torrance, California, 90502, United States
  • Valley View Internal Medicine not yet accepting patients
    Garden Grove, California, 92843, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02974322
Phase
Phase 3
Study Type
Interventional
Last Updated
September 28, 2017
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