Condition: Crohn's Disease · Sponsor: AbbVie
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Approximately 110 pediatric participants with CD will be enrolled at around 100 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneous…
This description comes directly from the study's public registry record.
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| Phoenix Children's Hospital /ID# 255766 | Phoenix, Arizona, United States | Recruiting |
| Arkansas Children's Hospital /ID# 255762 | Little Rock, Arkansas, United States | Recruiting |
| UCSF Benioff Children's Hospital - Oakland /ID# 258327 | Oakland, California, United States | Recruiting |
| Children's Hospital Colorado - Aurora /ID# 255764 | Aurora, Colorado, United States | Recruiting |
| Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437 | Orlando, Florida, United States | Recruiting |
| Indiana University Health Riley Hospital for Children /ID# 256454 | Indianapolis, Indiana, United States | Recruiting |
| Massachusetts General Hospital /ID# 255767 | Boston, Massachusetts, United States | Recruiting |
| MNGI Digestive Health, P. A. /ID# 255366 | Minneapolis, Minnesota, United States | Recruiting |
| Goryeb Childrens Hospital /ID# 256452 | Morristown, New Jersey, United States | Recruiting |
| Icahn School of Medicine at Mount Sinai /ID# 254880 | New York, New York, United States | Recruiting |
| Cleveland Clinic - Cleveland /ID# 256453 | Cleveland, Ohio, United States | Recruiting |
| Uza /Id# 255114 | Edegem, Antwerpen, Belgium | Recruiting |
+ 73 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05995353