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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02974322
Recruitment Status : Withdrawn (Sponsor decision not to start trial)
First Posted : November 28, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Crohn Disease Drug: GED-0301 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : November 17, 2018
Estimated Study Completion Date : December 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

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

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

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

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


Eligibility Criteria
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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.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Denesh Chitkara, MD Celgene Corporation
More Information
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02974322    
Other Study ID Numbers: GED-0301-CD-003
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

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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:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases