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NCT07071519 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT07071519 is a Phase 3 study of Ulcerative Colitis that is actively recruiting participants, run by AbbVie. The registered enrollment target is 120 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 17 states.
The verdict
NCT07071519, a Phase 3 study of Ulcerative Colitis, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 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 Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed. Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC 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 maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 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 a
Conditions Studied
Interventions
- DRUG Risankizumab
Study Locations (20)
Other
- Hospital Universite Enfants Reine Fabiola /ID# 271860 - Brussels
- General Hospital of Thessaloniki Hippokrateio /ID# 271939 - Thessaloniki
- Ospedale Infantile Burlo Garofolo /ID# 274442 - Trieste
Attica
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 270143 - Athens
- University General Hospital Attikon /ID# 272361 - Athens
Arizona
- Phoenix Children's Hospital /ID# 273015 - Phoenix
Florida
- Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585 - Miami
Georgia
- Childrens Center For Digestive Health Care /ID# 273228 - Atlanta
New Jersey
- Goryeb Children's Hospital /ID# 271801 - Morristown
Pennsylvania
- Upmc Children'S Hospital Of Pittsburgh /ID# 272328 - Pittsburgh
South Carolina
- Patewood Medical Campus /ID# 272477 - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-07-28 |
| Est. Completion | 2034-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07071519
The ClinicalTrials.gov registry entry for NCT07071519 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Risankizumab is the first listed.
NCT07071519 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Other, Attica, Arizona.
Frequently Asked Questions
What is clinical trial NCT07071519 about?
NCT07071519 is a clinical study titled "A Study to Learn More About How Risankizumab Works in Young Participants With 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 Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants w...
What is the current status of trial NCT07071519?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2025-07-28. Estimated completion is 2034-07.
What conditions does trial NCT07071519 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT07071519?
The interventions under investigation include: Risankizumab (DRUG).
Who is sponsoring clinical trial NCT07071519?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07071519 being conducted?
This trial has 20 study locations across Arizona, Florida, Georgia, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.