A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Public ClinicalTrials.gov record NCT07071519. 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, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis
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 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 and completing questionnaires.
Study identification
- NCT ID
- NCT07071519
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 120 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
- Jul 27, 2025
- Primary completion
- Jun 30, 2034
- Completion
- Jun 30, 2034
- Last update posted
- Sep 2, 2026
2025 – 2034
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital /ID# 273015 | Phoenix | Arizona | 85016 | Recruiting |
| Rady Children's Hospital /ID# 271873 | San Diego | California | 92123 | Recruiting |
| University of California San Francisco - Mission Bay /ID# 273022 | San Francisco | California | 94158 | Recruiting |
| Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue /ID# 271585 | Miami | Florida | 33155 | Recruiting |
| Childrens Center For Digestive Health Care /ID# 273228 | Atlanta | Georgia | 30342 | Recruiting |
| University of Chicago Medical Center /ID# 271588 | Chicago | Illinois | 60637 | Recruiting |
| Goryeb Children's Hospital /ID# 271801 | Morristown | New Jersey | 07962 | Recruiting |
| University Hospitals Cleveland Medical Center /ID# 271831 | Cleveland | Ohio | 44106 | Recruiting |
| The Children's Hospital of Philadelphia /ID# 273222 | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Upmc Children'S Hospital Of Pittsburgh /ID# 272328 | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Patewood Medical Campus /ID# 272477 | Greenville | South Carolina | 29615 | Recruiting |
| University of Texas - Southwestern Medical Center /ID# 271835 | Dallas | Texas | 75235 | Recruiting |
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 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07071519, 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 Sep 2, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07071519 live on ClinicalTrials.gov.