Treatment of Crohn's Disease
common.study.values.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.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods


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
participant.views.study.view.additional
participant.views.study.view.scientific-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
common.study.values.clinical-trial-id
NCT03105102
participant.views.study.view.id
xe7Brd