Clinical Trial

Treatment of Crohn's Disease

Study Description

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

The study consists of 3 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991. - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991. - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - placebo for risankizumab SC

placebo for risankizumab administered by subcutaneous (SC) injection

Drug - risankizumab IV

risankizumab administered by intravenous (IV) infusion

Drug - placebo for risankizumab IV

placebo for risankizumab administered by intravenous (IV) infusion

Drug - risankizumab SC

risankizumab administered by subcutaneous (SC) injection

Additional Information

Official Study Title

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

Clinical Trial ID

NCT03105102

ParticipAid ID

xe7Brd