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Risankizumab for Pediatric Crohn's Disease

This study is for children and teenagers aged 2 to 17 with moderately to severely active Crohn's disease (CD). It's looking at how risankizumab, a drug already approved for adults with CD, works in younger patients. Researchers want to understand how the drug moves through the body (pharmacokinetics), how well it helps reduce disease activity (efficacy), and if it causes any side effects (safety). To join, your child must have active CD with specific scores on disease activity and inflammation tests, and have not responded well to other treatments. The study aims to see if risankizumab can lead to clinical remission (a period where symptoms are greatly reduced or absent) and improve gut inflammation after about 64 weeks.

Study design
This interventional study plans to enroll 110 participants across different age groups. It will assess risankizumab given either intravenously (IV infusion) or subcutaneously (SC injection).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 64 weeks to measure drug levels and disease activity.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05995353

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
PHASE3Ages 2–17InterventionalTreatment
AbbVie
~110 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Risankizumab

At a glance

Recruiting sites
82 of 85 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Measured over At 64 weeks
+4 more outcomes measured

Conditions

Crohn's Disease

Explore related trials

Crohn Disease

Where it's being run

85 sites across 67 states
Turkey (Türkiye)4
Bulgaria3
Tokyo3
Seoul Teugbyeolsi3
Brussels Capital2
Alberta2
Beijing Municipality2
Guangdong2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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.

What this trial measures

  • Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical RemissionAt 64 weeks

    PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.

  • Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)At 64 weeks

    The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).

  • Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of RisankizumabUp to approximately Week 64

    Cmax of risankizumab

  • Cohorts 1 & 2: Time to Cmax (Tmax) of RisankizumabUp to approximately 64 weeks

    Tmax of risankizumab

  • Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of RisankizumabUp to approximately 64 weeks

    AUCtau of risankizumab