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

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

Timeline

Start

2016-04-04

Primary completion

2017-09-25

Completion

2017-11-09

Outcome

Outcome not reported

Stopped: “Study terminated by Sponsor following a recommendation from external DMC to terminate the ongoing Phase 3 CD studies; there were no new emergent safety findings”

Publications

• Marafini I, Stolfi C, Troncone E, Lolli E, Onali S, Paoluzi OA, Fantini MC, Biancone L, Calabrese E, Di Grazia A, Monteleone I, Lenti MV, Di Sabatino A, Monteleone G. A Pharmacological Batch of Mongersen that Downregulates Smad7 is Effective as Induction Therapy in Active Crohn's Disease: A Phase II, Open-Label Study. BioDrugs. 2021 May;35(3):325-336. doi: 10.1007/s40259-021-00482-x. Epub 2021 Apr 19.

Drugs

Indications