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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Celgene
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT02596893
First received: November 3, 2015
Last updated: August 31, 2017
Last verified: August 2017
  Purpose

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.


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, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (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 stool frequency and abdominal pain (US) OR 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 by Crohn's Disease Activity Index (CDAI) [ Time Frame: Week 12, Week 52 ]
    The proportion of subjects achieving clinical remission at Week12,Week 52

  • Corticosteroid-free clinical remission by Crohn's Disease Activity Index (CDAI) [ Time Frame: Week 52 ]
    The proportion of subjects who achieve corticosteroid-free clinical remission at Week 52 among subjects receiving oral corticosteroids at baseline

  • Adverse Events (AEs) [ Time Frame: Up to 52 weeks ]
    Number of participants with adverse events

  • Endoscopic remission by the Simple Endoscopic Score for Crohn's Disease (SES-CD) [ Time Frame: Week 52 ]
    Endoscopic remission week 52

  • Clinical remission by stool frequency and abdominal pain and Crohn's Disease Activity Index (CDAI) [ Time Frame: Week 12, Week 52 ]
    The proportion of subjects achieving clinical remission at Week 12, Week 52

  • Clinical Response by CDAI [ Time Frame: Week 12 ]
    The proportion of subjects achieving clinical response at Week 12

  • Endoscopic Response by SES-CD [ Time Frame: Week 12, Week 52 ]
    The proportion of subjects with a reduction from baseline in SES-CD at Week 52, Week 12

  • Sustained clinical remission by stool frequency and abdominal pain (US) OR CDAI (Rest of World) [ Time Frame: Week 12 AND Week 52 ]
    The proportion of subjects achieving clinical remission at both Week 12 AND Week 52


Estimated Enrollment: 1064
Actual Study Start Date: December 8, 2015
Estimated Study Completion Date: December 28, 2018
Estimated Primary Completion Date: September 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GED0301 160mg x 12 weeks followed by periodic 160 mg GED0301
GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 160 mg QD for 4 weeks and placebo QD for 4 weeks, until the the Week 52 Visit
Drug: GED-0301 Drug: Placebo
Experimental: GED0301 160mg x 12 weeks followed by periodic GED0301 40mg
GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 40 mg QD for 4 weeks and placebo QD for 4 weeks, until the Week 52 Visit
Drug: GED-0301 Drug: Placebo
Experimental: GED0301 160mg x 12 weeks followed by continuous GED0301 40mg
GED-0301 160 mg once daily (QD) for 12 weeks; followed by continuous GED-0301 40 mg QD, until the Week 52 Visit
Drug: GED-0301
Experimental: Placebo
Placebo once daily (QD) until the Week 52 Visit
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (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 ≥ 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.

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
  • 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.
  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 ClinicalTrials.gov identifier: NCT02596893

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

  Show 568 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Guillermo Rossiter, MD Celgene Corporation
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02596893     History of Changes
Other Study ID Numbers: GED-0301-CD-002
Study First Received: November 3, 2015
Last Updated: August 31, 2017

Keywords provided by Celgene:
Crohn's Disease
GED-0301
Mongersen
IBD
Safety
Efficacy

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

ClinicalTrials.gov processed this record on September 21, 2017