Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 80 Years|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||AbbVie|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|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|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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.
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.