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A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
NCT07071519 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07071519 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Other, Attica, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07071519?
The interventions under investigation include: Risankizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07071519?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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