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

Study Purpose

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 participants 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 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 or the Phase 2, open-label extension study M15-989, 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.

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	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participants who have entered and completed Study M16-006 or Study M15-991 or Study M15-989.

- Participants have completed the study M16-006 or M15-991 and have achieved clinical response.

Exclusion Criteria:

- Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .

- Participant who has 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 M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the participant unsuitable for this study.

- Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989.

- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989.

- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.

- Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.

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.	NCT03105102
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, 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, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn's Disease
Study Website:	View Trial Website

Arms & Interventions

Arms

Placebo Comparator: Double-blind Placebo for Risankizumab (Sub-Study 1)

Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.

Experimental: Double-blind Risankizumab Dose 1 (Sub-Study 1)

Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.

Experimental: Double-blind Risankizumab Dose 2 (Sub-Study 1)

Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.

Experimental: Maintenance Risankizumab Dose 1 (Sub-Study 2)

Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Experimental: Maintenance Risankizumab Dose 2 (Sub-Study 2)

Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Experimental: Open-label Risankizumab (Sub-Study 3)

Participants who completed Sub-study 1 or Sub-study 2 or Study M15-989 or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 beginning at Week 56.

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

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.

Phoenix VA Healthcare /ID# 162264, Phoenix, Arizona

Status

Recruiting

Address

Phoenix VA Healthcare /ID# 162264

Phoenix, Arizona, 85012

Site Contact

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