We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
Verified September 2017 by Celgene
Sponsor:
ClinicalTrials.gov Identifier:
NCT02974322
First Posted: November 28, 2016
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  Purpose

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

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: 798
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: December 24, 2018
Estimated Primary Completion Date: November 17, 2018 (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
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
GED-0301
Other Name: Mongersen
Placebo Comparator: Placebo once daily
Placebo once daily (QD)
Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974322


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Show 345 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Denesh Chitkara, MD Celgene Corporation
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02974322     History of Changes
Other Study ID Numbers: GED-0301-CD-003
First Submitted: November 23, 2016
First Posted: November 28, 2016
Last Update Posted: September 29, 2017
Last Verified: September 2017

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

Keywords provided by Celgene:
Crohn's Disease
GED-0301
Mongersen
Adolescent
Pediatric
Children

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases