A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Recruiting · Phase 3 · NCT05995353
Conditions: Crohn's Disease
At a glance
- Research payments reported, 2025
- $500,951
- U.S. investigators named
- 12
- Sites paid
- 12
- Planned or actual enrollment
- 110
About the trial
- Sponsor
- AbbVie
- Tested
- Risankizumab (drug), Risankizumab (drug)
- Dates
- Started 2023-12-11; completion 2029-04
- Results posted
- Not yet
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 1…
From ClinicalTrials.gov, last updated 2026-10-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $500,951 in research payments for this study in 2025 (118 payments).
Products named: Skyrizi
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Travis D. Ayers, M.D. Pediatric Gastroenterology · Little Rock, AR
- Brad A. Pasternak, MD Pediatric Gastroenterology · Phoenix, AZ
- Sabina A. Ali, MD Pediatric Gastroenterology · Oakland, CA
- Edward Hoffenberg, MD Pediatric Gastroenterology · Aurora, CO
- Jeffrey A. Bornstein, MD Pediatric Gastroenterology · Orlando, FL
- Xiaoyi Zhang, M.D., PH.D. Pediatric Gastroenterology · Indianapolis, IN
- Jess L. Kaplan, MD Pediatrics · Boston, MA
- Ramalingam Arumugam, MD Pediatric Gastroenterology · Saint Paul, MN
- Oren Koslowe Pediatric Gastroenterology · Morristown, NJ
- David S. Dunkin, M.D. Pediatric Gastroenterology · New York, NY
- Jacob Kurowski, M.D. Pediatric Gastroenterology · Cleveland, OH
- Antonio I. Del Valle, M.D. Pediatric Gastroenterology · San Juan, PR
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Clinical Research Puerto Rico Inc $103,354
- Icahn School of Med at Mt Sinai $98,073
- Mngi Digestive Health PA $90,510
- Indiana University $72,981
- Children's Hospital Colorado, CO $36,846
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $29,296
- Cleveland Clinic, OH $23,132
- Orlando Health, FL $15,650
- Phoenix Children's Hospital, AZ $15,275
- Massachusetts General Hospital, MA $9,752
- Morristown Medical Center, NJ $3,383
- Arkansas Childrens Research $2,700
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.