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

NCT02596893 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 701

Last updated 2019-08-28

Study results available
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Summary

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. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

Conditions

  • Crohn Disease

Interventions

DRUG

GED-0301

DRUG

Placebo

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Guillermo Rossiter, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-08
Primary Completion
2018-01-05
Completion
2018-01-05

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Malaysia
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02596893 on ClinicalTrials.gov