A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT02974322|
Recruitment Status : Withdrawn (Sponsor decision not to start trial)
First Posted : November 28, 2016
Last Update Posted : November 14, 2017
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: GED-0301 1 x 160 mg once daily
GED-0301 1 x 160 mg tablet once daily (QD)
Other Name: Mongersen
Experimental: GED-0301 - 4 x 40 mg once daily
GED-0301 4 x 40 mg tablets once daily (QD)
Other Name: Mongersen
Placebo Comparator: Placebo once daily
Placebo once daily (QD)
- 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.
- 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
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
|Study Director:||Denesh Chitkara, MD||Celgene Corporation|