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.
Public ClinicalTrials.gov record NCT05782907. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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 Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-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 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 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 be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. 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.
Study identification
- NCT ID
- NCT05782907
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 122 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 5, 2023
- Primary completion
- Jul 31, 2028
- Completion
- Sep 30, 2031
- Last update posted
- May 13, 2026
2023 – 2031
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital /ID# 250135 | Phoenix | Arizona | 85016-7710 | — |
| Arkansas Children's Hospital /ID# 250106 | Little Rock | Arkansas | 72202 | — |
| Kindred Medical Institute - Corona /ID# 255484 | Corona | California | 92879-3104 | — |
| UCSF Benioff Children's Hospital - Oakland /ID# 255067 | Oakland | California | 94609 | — |
| Lucile Packard Children's Hospital /ID# 258430 | Palo Alto | California | 94304 | — |
| Children's Hospital Colorado - Aurora /ID# 250110 | Aurora | Colorado | 80045 | — |
| Nemours/Alfred duPont Hospital for Children /ID# 255483 | Wilmington | Delaware | 19803 | — |
| Childrens Healthcare of Atlanta - Center for Advanced Pediatrics /ID# 255069 | Atlanta | Georgia | 30329 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 254505 | Chicago | Illinois | 60611 | — |
| OSF St. Francis Medical Center /ID# 256968 | Peoria | Illinois | 61637-0001 | — |
| Massachusetts General Hospital /ID# 250142 | Boston | Massachusetts | 02114 | — |
| Boston Children's Hospital /ID# 250108 | Boston | Massachusetts | 02115 | — |
| NYU Langone Hospital - Long Island /ID# 250136 | Mineola | New York | 11501 | — |
| The Mount Sinai Hospital /ID# 250141 | New York | New York | 10029 | — |
| Univ NC Chapel Hill /ID# 254541 | Chapel Hill | North Carolina | 27514-4220 | — |
| Levine Children's Hospital /ID# 250131 | Charlotte | North Carolina | 28203 | — |
| UH Cleveland Medical Center /ID# 250134 | Cleveland | Ohio | 44106 | — |
| Children's Hospital of Philadelphia - Main /ID# 258773 | Philadelphia | Pennsylvania | 19104-4319 | — |
| Children's Specialty Group /ID# 256966 | Norfolk | Virginia | 23507 | — |
| University of Wisconsin - Madison /ID# 250632 | Madison | Wisconsin | 53715-1218 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05782907, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05782907 live on ClinicalTrials.gov.