NCT02974322

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	GED-0301	GED-0301
DRUG	Placebo	Placebo

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-11-17
• Completion: 2018-12-24
• First posted: 2016-11-28
• Last updated: 2017-11-14

Locations

311 sites across 30 countries: United States, Australia, Austria, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study