NCT02685683

Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease

A Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once daily in patients with active Crohn's Disease

Detailed description

Subjects will be screened to provide 20 enrolled subjects who complete 12 weeks of mongersen (GED-0301) 160 mg QD treatment as open-label therapy. The study will consist of 4 periods: * Screening Period - up to 4 weeks * Induction Period - 12 weeks (Week 0 Visit through Week 12 Visit) * Maintenance Period - 88 weeks (after Week 12 Visit through Week 100 Visit) * Follow-up Period - 4 weeks (ie, no IP taken) Subjects who prematurely discontinue treatment from this study prior to Week 100 will have an Early Termination Visit and also enter the 4-week Follow-up Period. At the Screening Visit, all subjects who meet the entrance criteria will be eligible to enter the study. The number of subjects with previous exposure to Tumor Necrosis Factor-Alpha (TNF-α) blockers is targeted to be approximately 40% (ie, approximately 8 subjects).

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2016-04-04
• Primary completion: 2017-09-25
• Completion: 2017-11-09
• First posted: 2016-02-19
• Last updated: 2018-08-14

Locations

2 sites across 1 country: Italy