Crohn's Disease study: Risankizumab
Official title A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT05995353
What this study is testing
What is Risankizumab?
This is an investigational medicine being studied to treat Crohn's disease in children. It is designed to block a specific protein in the body that causes inflammation.
Also referred to as Skyrizi.
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 checks how the drug works, how it moves through the body, and if it is safe for kids.
- Who it's for
- Children aged 2 to 17 with moderately to severely active Crohn's disease who did not respond well to other treatments.
- What's involved
- Participants get the drug through an IV or under the skin. They will have regular check-ups, blood tests, and fill out questionnaires.
- Time commitment
- The study lasts up to 4 years, including a 12-week start, a 52-week middle part, and a long follow-up period.
- 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
- Pediatric individuals, 2 to \< 18 years old
- Must have moderately to severely active CD, as defined by the PCDAI score \> 30 assessed at Baseline
- Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for...
- Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not...
You likely can't join if
- History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study...
- Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
- A diagnosis of CD prior to 2 years of age.
- A diagnosis or suspected diagnosis of a primary immunodeficiency.
- Active abscess (abdominal or perianal);
- Symptomatic bowel strictures;
See the full eligibility criteria
- Pediatric individuals, 2 to \< 18 years old
- Must have moderately to severely active CD, as defined by the PCDAI score \> 30 assessed at Baseline
- Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)
- Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for people in France, Italy, Netherlands, Spain...
- History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class
- Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
- A diagnosis of CD prior to 2 years of age.
- A diagnosis or suspected diagnosis of a primary immunodeficiency.
- Active abscess (abdominal or perianal);
- Symptomatic bowel strictures;
- \> 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
- Fulminant colitis;
- Toxic megacolon;
- Or any other manifestation that might require surgery while enrolled in the study.
- Ostomy or ileoanal pouch.
- Diagnosis of short gut or short bowel syndrome.
- Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of \>3 bowel resections.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Oakland, California, United States
- Aurora, Colorado, United States
- Orlando, Florida, United States
- Indianapolis, Indiana, United States
- Waltham, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Edegem, Antwerpen, Belgium
- Brussels, Brussels Capital, Belgium
- Jette, Brussels Capital, Belgium
- Leuven, Vlaams-Brabant, Belgium
- Brussels, Belgium
- Liège, Belgium
- Plovdiv, Bulgaria
- Varna, Bulgaria
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
+ 52 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; Oakland, California, United States; Aurora, Colorado, United States; Orlando, Florida, United States; Indianapolis, Indiana, United States; Waltham, Massachusetts, United States and 66 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.