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NCT05782907 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study of Ulcerative Colitis, sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
- 20
- Study locations
NCT05782907: Active Phase 3 study of Ulcerative Colitis, sponsored by AbbVie.
NCT05782907 is a Phase 3 study of Ulcerative Colitis that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 122 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05782907, a Phase 3 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The AMS is a composite of the following subscores: stool frequency subscore (SFS), rectal bleeding subscore (RBS) and endoscopy subscore (MES). AMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as an AMS \< or = 2, with SFS \< or = 1 and not higher than baseline, RBS of 0, and MES \< or = 1.
Conditions Studied
Interventions
- DRUG Upadacitinib
Study Locations (20)
California
- Kindred Medical Institute - Corona /ID# 255484 - Corona
- UCSF Benioff Children's Hospital - Oakland /ID# 255067 - Oakland
- Lucile Packard Children's Hospital /ID# 258430 - Palo Alto
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 254505 - Chicago
- OSF St. Francis Medical Center /ID# 256968 - Peoria
Massachusetts
- Massachusetts General Hospital /ID# 250142 - Boston
- Boston Children's Hospital /ID# 250108 - Boston
New York
- NYU Langone Hospital - Long Island /ID# 250136 - Mineola
- The Mount Sinai Hospital /ID# 250141 - New York
North Carolina
- Univ NC Chapel Hill /ID# 254541 - Chapel Hill
- Levine Children's Hospital /ID# 250131 - Charlotte
Arizona
- Phoenix Children's Hospital /ID# 250135 - Phoenix
Arkansas
- Arkansas Children's Hospital /ID# 250106 - Little Rock
Colorado
- Children's Hospital Colorado - Aurora /ID# 250110 - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2023-11-06 |
| Est. Completion | 2033-10 |
| Phase | Phase 3 |
What the registry record for NCT05782907 still lists
NCT05782907 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Upadacitinib is the first listed.
NCT05782907 names 20 study sites across 14 states, led by California, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05782907 about?
NCT05782907 is a clinical study titled "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.". 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 dise...
What is the current status of trial NCT05782907?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2023-11-06. Estimated completion is 2033-10.
What conditions does trial NCT05782907 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT05782907?
The interventions under investigation include: Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT05782907?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05782907 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05782907's enrollment target sits among peer trials
122 59th of 122 higher than 63 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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