Clinical trial

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis

Name

M16-067

Description

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Trial arms

Trial start

2018-03-07

Estimated PCD

2022-11-09

Trial end

2023-05-11

Status

Completed

Phase

Early phase I

Treatment

risankizumab IV

risankizumab intravenous (IV) infusion

Arms:

Substudy 1, Induction 1: Double-blind Risankizumab Dose 1, Substudy 1, Induction 1: Double-blind Risankizumab Dose 2, Substudy 1, Induction 1: Double-blind Risankizumab Dose 3, Substudy 1, Induction 1: Open-label Risankizumab Dose 1, Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a), Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b), Substudy 2, Induction 1: Double-blind Placebo, Substudy 2, Induction 1: Double-blind Risankizumab Dose 1, Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a), Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)

Other names:

ABBV-066, BI 655066

placebo for risankizumab

Arms:

Substudy 1, Induction 1: Double-blind Placebo, Substudy 2, Induction 1: Double-blind Placebo

risankizumab SC

risankizumab subcutaneous (SC) injection

Arms:

Substudy 1, Induction 2: Double-blind Risankizumab Dose 2, Substudy 1, Induction 2: Double-blind Risankizumab Dose 3, Substudy 2, Induction 2: Double-blind Risankizumab Dose 2, Substudy 2, Induction 2: Double-blind Risankizumab Dose 3

Other names:

ABBV-066, BI 655066

Size

1558

Primary endpoint

Sub-Study 1 and Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score

Week 12

Eligibility criteria

Inclusion Criteria: * Male or female aged \>=18 to \<= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit. * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline. * Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore. * Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies. * Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control. Exclusion Criteria: * Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis. * Participant receiving prohibited medications and treatment. * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. * Participant with currently known complications of UC (e.g., megacolon). * No known active Coronavirus Disease - 2019 (COVID-19) infection.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1558, 'type': 'ACTUAL'}}

Updated at

2023-08-01

1 organization

1 product

1 indication

Organization

AbbVie

Product

Risankizumab

Indication

Ulcerative Colitis