Ulcerative Colitis study: Risankizumab
Official title A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
ClinicalTrials.gov ID: NCT07071519
What this study is testing
What is Risankizumab?
This is an investigational medicine being studied to treat moderate to severe ulcerative colitis in children. It is designed to block a specific protein in the body that causes inflammation in the gut.
Also referred to as ABBV-066.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to learn how the body processes Risankizumab and to check if it is safe and effective for treating moderate to severe ulcerative colitis in children.
- Who it's for
- The study is looking for children and teenagers aged 2 to 17 who have moderate to severe ulcerative colitis.
- What's involved
- Participants will receive Risankizumab through an IV drip or under-the-skin injection. They will also have regular medical checks, blood tests, and fill out questionnaires to monitor their health.
- Time commitment
- The study lasts up to about 5 years, including a 12-week start, a 52-week middle phase, and a long follow-up period, with regular visits to a hospital or clinic.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
- Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: aminosalicylates (except in countries where...
You likely can't join if
- Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal...
- Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- San Diego, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Morristown, New Jersey, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Greenville, South Carolina, United States
- Dallas, Texas, United States
- Brussels, Brussels Capital, Belgium
- Brussels, Belgium
- Liège, Belgium
- Juiz de Fora, Minas Gerais, Brazil
- Curitiba, Paraná, Brazil
- São Paulo, Brazil
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
+ 47 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; San Diego, California, United States; San Francisco, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 61 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.