GED-0301-CD-003 - ACTIVE CROHN’S DISEASE

  • Research type

    Research Study

  • Full 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 ADULT AND ADOLESCENT SUBJECTS WITH ACTIVE CROHN’S DISEASE

  • IRAS ID

    220006

  • Contact name

    Jeffrey Butterworth

  • Contact email

    jeff.butterworth@sath.nhs.uk

  • Sponsor organisation

    Celgene Corporation

  • Eudract number

    2015-001924-40

  • Clinicaltrials.gov Identifier

    NCT02974322

  • Clinicaltrials.gov Identifier

    U1111-1190-4462, Universal Trial Number (UTN)

  • Duration of Study in the UK

    1 years, 4 months, 30 days

  • Research summary

    The purpose of this clinical research study is to test the effects of an investigational study medication, GED-0301, in order to find out if GED-0301 can or cannot improve the symptoms of Crohn’s disease. The study will test GED-0301, given in 2 tablet strengths to adult and adolescent subjects (aged 12 to 17 years, inclusive), compared to placebo. The placebo is a “sugar pill” that contains no active study medication (or GED-0301), but looks exactly like the active study medication tablet. This study will test how well the body tolerates GED-0301 and the effect that GED-0301 has on the symptoms of Crohn’s disease. This is a phase 3 study, which means that the investigational study medication has been tested for safety and is now being tested in a larger number of patients.
    Subjects will participate for a maximum of 20 weeks in this study: up to 4 weeks in the Screening Period; 12 weeks in the Double-blind Treatment Period; and 4 weeks in the Follow-up Period.

    About 798 subjects worldwide will take part in this study.

    All subjects who complete the study will have the option to enter a long-term active-treatment study under protocol GED-0301-CD-004 at the Week 12 Visit.

    This study is being organised by Celgene Corporation.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    17/NW/0172

  • Date of REC Opinion

    17 May 2017

  • REC opinion

    Further Information Favourable Opinion