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||16 Years - 80 Years|
- - Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit.
- - Diagnosis of CD for at least 3 months prior to Baseline
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
- Demonstrated intolerance or inadequate response to biologic therapy for CD
- If female, subject must meet the contraception recommendations
Exclusion Criteria:- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis - Subjects with unstable doses of concomitant Crohn's disease therapy - Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
- - Prior exposure to p19 inhibitors (e.g., risankizumab).
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, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Placebo Comparator: Placebo (Induction Period 1)
Participants randomized to receive placebo for risankizumab in Induction Period 1.
Experimental: Risankizumab Dose 1 (Induction Period 1)
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
Experimental: Risankizumab Dose 1 (Induction Period 2)
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Experimental: Risankizumab Dose 2 (Induction Period 1)
Participants randomized to receive risankizumab dose 2 in Induction Period 1
Experimental: Risankizumab dose 3 (Induction period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Experimental: Risankizumab Dose 2 (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Drug: - placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.
Drug: - risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Drug: - risankizumab IV
risankizumab administered as intravenous (IV) infusion.
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.