A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

Study Purpose

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: 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participants who have completed Study M16-065 or 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 M16-065 or 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 M16-065 and M16-067

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03398135
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AbbVie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	AbbVie Inc.
Principal Investigator Affiliation	AbbVie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Egypt, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis (UC)
Study Website:	View Trial Website

Arms & Interventions

Arms

Placebo Comparator: Substudy 1: Double-blind Placebo

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

Experimental: Substudy 1: Double-blind Risankizumab Dose 1

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

Experimental: Substudy 1: Double-blind Risankizumab Dose 2

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

Experimental: Substudy 2: Open-label Risankizumab Dose 1

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

Experimental: Substudy 2: Open-label Risankizumab Dose 2

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

Experimental: Substudy 3: Open-label Extension Risankizumab

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

Interventions

Drug: - risankizumab

subcutaneous (SC) injection

Drug: - placebo for risankizumab

subcutaneous (SC) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Coronado, California

Status

Recruiting

Address

Southern California Res. Ctr. /ID# 169659

Coronado, California, 92118-1408

Site Contact

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