Risankizumab for Moderately to Severely Active Crohn's Disease
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
Recruiting
Phase 3Interventional Study
Crohn's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
110 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for children and teenagers with Crohn's Disease who have not responded well to other treatments. Participants will receive a drug called risankizumab to see how it helps their condition over time.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 2 and 18 years old.
I have been diagnosed with moderately to severely active Crohn's Disease.
I have evidence of inflammation in my intestines.
I have not responded well or have had bad reactions to certain Crohn's Disease medications.
You may not be able to join if
I have a history of hereditary fructose intolerance.
I currently have ulcerative colitis or indeterminate colitis.
I was diagnosed with Crohn's Disease before I was 2 years old.
I have a primary immunodeficiency.
I have active complications from Crohn's Disease that might need surgery.
I have had bowel surgery in the last 3 months (except minor surgeries).
I have an ostomy or ileoanal pouch.
I have short gut syndrome.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies.
Risa…
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies.
Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD 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 induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Approximately 110 pediatric participants with CD will be enrolled at around 100 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.
Trial Locations
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Eligibility Criteria
Inclusion 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 …
Inclusion 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 subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies
Exclusion Criteria:
* 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
* Any of the following medical disorders:
1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
2. A diagnosis of CD prior to 2 years of age.
3. A diagnosis or suspected diagnosis of a primary immunodeficiency.
4. Currently known complications of CD such as:
* 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.
5. Ostomy or ileoanal pouch.
6. Diagnosis of short gut or short bowel syndrome.
7. 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.
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