A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Ulcerative Colitis (UC)

Treatments: Drug: placebo for risankizumab; Drug: risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03398135

2023-506994-36-00 (Other Identifier)

2016-004676-22 (EudraCT Number)

M16-066

Details and patient eligibility

About

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

Enrollment: 1,242 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Exclusion criteria

• Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
• Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,242 participants in 8 patient groups, including a placebo group

Substudy 1: Double-blind Placebo

Placebo Comparator group

Description:

Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.

Treatment:

Drug: placebo for risankizumab

Substudy 1: Double-blind Risankizumab Dose 1

Experimental group

Description:

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Treatment:

Drug: risankizumab

Substudy 1: Double-blind Risankizumab Dose 2

Experimental group

Description:

Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.

Treatment:

Drug: risankizumab

Substudy 2: Open-label (OL) Clinical Assessment Risankizumab

Experimental group

Description:

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Treatment:

Drug: risankizumab

Substudy 2: OL Therapeutic Drug Monitoring Risankizumab

Experimental group

Description:

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Treatment:

Drug: risankizumab

Substudy 3: OL Extension Risankizumab

Experimental group

Description:

Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.

Treatment:

Drug: risankizumab

OL Continuous Treatment Extension - Dose 1

Experimental group

Description:

Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.

Treatment:

Drug: risankizumab

OL Continuous Treatment Extension - Dose 2

Experimental group

Description:

Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.

Treatment:

Drug: risankizumab