Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Active, not recruiting · Phase 3 · NCT05782907
Conditions: Ulcerative Colitis
At a glance
- Research payments reported, 2025
- $666,599
- U.S. investigators named
- 20
- Sites paid
- 20
- Planned or actual enrollment
- 122
About the trial
- Sponsor
- AbbVie
- Tested
- Upadacitinib (drug)
- Dates
- Started 2023-11-06; completion 2031-10
- Results posted
- Not yet
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receiv…
From ClinicalTrials.gov, last updated 2026-05-14. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $666,599 in research payments for this study in 2025 (112 payments).
Products named: Rinvoq
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
- Ashish S. Patel, MD Pediatric Gastroenterology · Phoenix, AZ
- Sabina A. Ali, MD Pediatric Gastroenterology · Oakland, CA
- Jonathan D. Moses, MD Pediatric Gastroenterology · Palo Alto, CA
- Edward Hoffenberg, MD Pediatric Gastroenterology · Aurora, CO
- Zarela L. Molle-rios, MD Pediatric Gastroenterology · Wilmington, DE
- Barbara J. Niklinska Schirtz, MD Pediatrics · Atlanta, GA
- Joseph M. Runde, D.O Pediatric Gastroenterology · Chicago, IL
- Ian K. Kang, M.D. Pediatric Gastroenterology · Baton Rouge, LA
- Athos Bousvaros, MD, MPH Pediatric Gastroenterology · Boston, MA
- Jess L. Kaplan, MD Pediatrics · Boston, MA
- Tiffany M. Linville, MD Pediatric Gastroenterology · Charlotte, NC
- David S. Dunkin, M.D. Pediatric Gastroenterology · New York, NY
- Tuvia A. Marciano, DO Pediatric Gastroenterology · Mineola, NY
- Thomas J. Sferra, MD Pediatric Gastroenterology · Cleveland, OH
- Lindsey G. Albenberg, DO Pediatric Gastroenterology · Philadelphia, PA
- Antonio I. Del Valle, M.D. Pediatric Gastroenterology · San Juan, PR
- Nancy U. Yokois, M.D. Pediatric Gastroenterology · Norfolk, VA
- Matthew D. Egberg, M.D. Student in an Organized Health Care Education/Training Program · Madison, WI
- Daniel M. O'connell, M.D. Pediatric Gastroenterology · Madison, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Children's Hospital Colorado, CO $99,307
- The Board of Trustees of the Leland $92,616
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $79,459
- Clinical Research Puerto Rico Inc $71,402
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $64,530
- Wake Forest University $49,270
- Uh Cleveland Medical Center, OH $36,316
- Phoenix Children's Hospital, AZ $31,710
- Boston Children's Hospital, MA $25,770
- Children S Healthcare of Atlanta $21,588
- University of North Carolina $20,092
- Icahn School of Med at Mt Sinai $13,588
- Nemours Childrens Hospital, Florida, FL $13,543
- New York University $10,481
- Children's Hospital of Philadelphia, PA $9,926
- Board of Regents of the University $9,529
- Osf Heart of Mary Medical Center, IL $9,459
- Arkansas Childrens Research $5,475
- Massachusetts General Hospital, MA $1,526
- Children S Specialty Group PLLC $1,013
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.