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 (NCT05995353)
A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
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 subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Who can join: Review the eligibility criteria below.
Location: Phoenix Children's Hospital /ID# 255766 — Phoenix, Arizona
Age range: 2 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (85 Sites)
Showing the first 25 of 85 sites.
- Phoenix Children's Hospital /ID# 255766 — Phoenix, Arizona
- Arkansas Children's Hospital /ID# 255762 — Little Rock, Arkansas
- UCSF Benioff Children's Hospital - Oakland /ID# 258327 — Oakland, California
- Children's Hospital Colorado - Aurora /ID# 255764 — Aurora, Colorado
- Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437 — Orlando, Florida
- Indiana University Health Riley Hospital for Children /ID# 256454 — Indianapolis, Indiana
- Massachusetts General Hospital /ID# 255767 — Boston, Massachusetts
- MNGI Digestive Health, P. A. /ID# 255366 — Minneapolis, Minnesota
- Goryeb Childrens Hospital /ID# 256452 — Morristown, New Jersey
- Icahn School of Medicine at Mount Sinai /ID# 254880 — New York, New York
- Cleveland Clinic - Cleveland /ID# 256453 — Cleveland, Ohio
- Uza /Id# 255114 — Edegem, Antwerpen
- Cliniques Universitaires UCL Saint-Luc /ID# 255108 — Brussels, Brussels Capital
- Universitair Ziekenhuis Brussel /ID# 255109 — Jette, Brussels Capital
- Groupe Sante CHC - Clinique du MontLegia /ID# 255620 — Liège, Liege
- Universitair Ziekenhuis Leuven /ID# 255098 — Leuven, Vlaams-Brabant
- Hospital Universite Enfants Reine Fabiola /ID# 255112 — Brussels,
- UMHAT Sveti Georgi /ID# 255386 — Plovdiv,
- Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384 — Sofia,
- UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358 — Varna,
- Alberta Children's Hospital /ID# 255357 — Calgary, Alberta
- Edmonton Clinic Health Academy /ID# 255361 — Edmonton, Alberta
- BC Children's Hospital /ID# 255359 — Vancouver, British Columbia
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598 — London, Ontario
- Beijing Children's Hospital /ID# 256081 — Beijing, Beijing Municipality
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) — Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease — Birmingham, Alabama
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. — Sun City, Arizona
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. — Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients — San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis — Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.