A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease

Phase 1 Completed 64 enrolled Celgene Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.

Timeline

Start: 2015-04-08
Primary completion: 2016-09-06
Completion: 2017-12-14

Publications

Feagan BG, Sands BE, Rossiter G, Li X, Usiskin K, Zhan X, Colombel JF. Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients With Active Crohn's Disease. Gastroenterology. 2018 Jan;154(1):61-64.e6. doi: 10.1053/j.gastro.2017.08.035. Epub 2017 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MONGERSEN SODIUM	Antisense oligonucleotide	40 mg	Oral
Subject	MONGERSEN SODIUM	Antisense oligonucleotide	160 mg	Oral

A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease

Summary

Timeline

Publications

Drugs

Indications