Gastroenterology/Bariatrics Clinical Trial - Abbvie - M16-000

Status:

In Process (Study opening soon)

ClinicalTrials.gov:

NCT03105102

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 subjects 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 subjects 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 subjects who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989."

Drug

Drug: Risankizumab IV, Risankizumab SC, Placebo for IV, Placebo for SC

Trial Type

Interventional

Age Range

18 years or older

Condition

Weight loss Crohn's Disease

Keywords

Weight loss | Crohn's Disease | risankizumab | Abbvie