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Trial record 2 of 11 for:    crohn's celgene

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by Celgene
Information provided by (Responsible Party):
Celgene Identifier:
First received: November 23, 2016
Last updated: March 31, 2017
Last verified: March 2017

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.

Condition Intervention Phase
Crohn Disease
Drug: GED-0301
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-blind, Multicenter, Induction Study to Investigate the Efficacy and Safety of GED-0301 For the Treatment of Subjects With Active Crohn's Disease

Resource links provided by NLM:

Further study details as provided by Celgene:

Primary Outcome Measures:
  • Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and Crohn's Disease Activity Index (CDAI) (Rest of World) [ Time Frame: week 12 ]
    The proportion of subjects achieving clinical remission at Week 12.

Secondary Outcome Measures:
  • Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and CDAI [ Time Frame: Week 4, week 12 ]
    The proportion of subjects achieving clinical remission at Week 4, Week 12.

  • Endoscopic improvement by the Simple Endoscopic Score for Crohn's Disease (SES-CD) [ Time Frame: Week 12 ]
    Endoscopic improvement of the mucosa at Week 12.

  • Clinical response defined by CDAI [ Time Frame: Week 4, week 12 ]
    The proportion of subjects achieving clinical response at Week 4, Week 12.

  • Clinical remission defined by PCDAI [ Time Frame: Week 12 ]
    The proportion of subjects achieving clinical remission at Week 12 (adolescent subjects only).

  • Adverse Events (AEs) [ Time Frame: Up to 20 weeks ]
    Incidence and severity of adverse events

  • Pharmacokinetics (PK)- plasma concentration of GED-0301 [ Time Frame: Week 4, week 8 ]
    The plasma concentration of GED-0301 at Week 4, Week 8

Estimated Enrollment: 799
Anticipated Study Start Date: April 15, 2017
Estimated Study Completion Date: February 24, 2018
Estimated Primary Completion Date: December 2, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GED-0301 1 x 160 mg once daily
GED-0301 1 x 160 mg tablet once daily (QD)
Drug: GED-0301
Other Name: Mongersen
Experimental: GED-0301 - 4 x 40 mg once daily
GED-0301 4 x 40 mg tablets once daily (QD)
Drug: GED-0301
Other Name: Mongersen
Placebo Comparator: Placebo once daily
Placebo once daily (QD)
Drug: Placebo


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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).

Exclusion Criteria:

• 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02974322

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599

  Show 275 Study Locations
Sponsors and Collaborators
Study Director: Denesh Chitkara, MD Celgene Corporation
  More Information

Responsible Party: Celgene Identifier: NCT02974322     History of Changes
Other Study ID Numbers: GED-0301-CD-003
Study First Received: November 23, 2016
Last Updated: March 31, 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on April 26, 2017