A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Summary

The study consists of 4 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 intravenous 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, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
* Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
* OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

Conditions

• Crohn's Disease

Interventions

DRUG

Placebo for Risankizumab SC

Placebo for Risankizumab SC Subcutaneous (SC) Injection

DRUG

Risankizumab IV

Risankizumab IV Intravenous (IV) infusion

DRUG

Placebo for Risankizumab IV

Placebo for Risankizumab IV Intravenous (IV) infusion

DRUG

Risankizumab SC

Risankizumab SC Subcutaneous (SC) injection

DRUG

Risankizumab On-Body Injector (OBI)

Subcutaneous (SC) injection; on-body injector (OBI)

Sponsors & Collaborators

• AbbVie

  lead INDUSTRY

Principal Investigators

• ABBVIE INC. · AbbVie

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-09

Primary Completion

2026-05-31

Completion

2026-05-31

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Austria
• Belarus
• Belgium
• Bosnia and Herzegovina
• Bulgaria
• Canada
• Chile
• China
• Colombia
• Croatia
• Czechia
• Denmark
• Egypt
• Estonia
• France
• Germany
• Greece
• Hong Kong
• Ireland
• Israel
• Italy
• Japan
• Latvia
• Lithuania
• Malaysia
• Mexico
• Netherlands
• New Zealand
• Norway
• Poland
• Portugal
• Romania
• Russia
• Serbia
• Singapore
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Ukraine
• United Kingdom

Study Locations