Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease (NCT06332534)
A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
🩺 Plain-English Summary (8th-Grade Level)
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given (UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) 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: UCSF Benioff Children's Hospital - Oakland /ID# 262217 — Oakland, California
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.
- UCSF Benioff Children's Hospital - Oakland /ID# 262217 — Oakland, California
- Lucile Packard Children's Hospital /ID# 262193 — Palo Alto, California
- Children's Hospital Colorado - Aurora /ID# 262207 — Aurora, Colorado
- Connecticut Children's Medical Center - Hartford /ID# 262256 — Hartford, Connecticut
- OSF St. Francis Medical Center /ID# 262192 — Peoria, Illinois
- Indiana University Health Riley Hospital for Children /ID# 262215 — Indianapolis, Indiana
- Boston Children's Hospital /ID# 262191 — Boston, Massachusetts
- MNGI Digestive Health, P. A. /ID# 262204 — Minneapolis, Minnesota
- Icahn School of Medicine at Mount Sinai /ID# 262216 — New York, New York
- Univ NC Chapel Hill /ID# 262198 — Chapel Hill, North Carolina
- UH Cleveland Medical Center /ID# 262188 — Cleveland, Ohio
- Children's Hospital of Philadelphia - Main /ID# 262197 — Philadelphia, Pennsylvania
- Sydney Children's Hospital /ID# 262352 — Randwick, New South Wales
- Children's Hospital at Westmead /ID# 262350 — Westmead, New South Wales
- Queensland Children's Hospital /ID# 262351 — South Brisbane, Queensland
- Monash Health - Monash Medical Centre - Clayton /ID# 262878 — Clayton, Victoria
- Perth Children'S Hospital /ID# 272905 — Perth, Western Australia
- Uza /Id# 261745 — Edegem, Antwerpen
- Cliniques Universitaires UCL Saint-Luc /ID# 261741 — Brussels, Brussels Capital
- Universitair Ziekenhuis Leuven /ID# 261740 — Leuven, Vlaams-Brabant
- Hospital Universite Enfants Reine Fabiola /ID# 261744 — Brussels,
- CHR de la Citadelle /ID# 261749 — Liège,
- UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 261750 — Namur,
- Galileo Medical Research Ltda /ID# 262602 — Juiz de Fora, Minas Gerais
- Hospital Pequeno Príncipe /ID# 262600 — Curitiba, Paraná
📞 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.