18
Participants
Start Date
April 4, 2016
Primary Completion Date
September 25, 2017
Study Completion Date
November 9, 2017
GED-0301
During Induction period patient will receive mongersen 160 mg daily for 12 weeks. This study also offers subjects the option to continue with maintenance treatment at the discretion of the Investigator, beginning after the Week 12 Visit with alternating no IP for 4 weeks, followed by mongersen (GED-0301) 160 mg QD for 4 weeks, up through the Week 52 Visit during the Maintenance Period. At Week 52, subjects who have achieved an endoscopic improvement of \>50% from baseline based on the SES-CD, as assessed by the central reader, and clinical improvement (HBI \<7), will have the option to continue receiving treatment for an additional year, up through Year 2 (ie, the Week 100 Visit).
Fondazione IRCCS Policlinico San Matteo, Pavia
Policlinico Tor Vergata, Rome
Lead Sponsor
Celgene
INDUSTRY