Back to search results

A Study of Risankizumab for Young Participants with Ulcerative Colitis

This study is looking into how Risankizumab works in children and teenagers with moderate to severe ulcerative colitis (UC), a condition that causes inflammation and bleeding in the large intestine. Risankizumab is already approved for adults with UC. Researchers want to understand how the drug moves through the bodies of young people and how safe and effective it is for them. They will be watching for any side effects and changes in UC activity. You might be able to join if you are between 2 and 17 years old, have active UC, and haven't responded well to other UC medications.

Study design
This is an interventional study planning to enroll 120 participants. It includes different groups (cohorts) based on age.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure drug levels in the body up to Week 64.

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

NCT07071519

A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

Recruiting
PHASE3Ages 2–17InterventionalTreatment
AbbVie
~120 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Risankizumab

At a glance

Recruiting sites
57 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
Measured over At Week 64
+7 more outcomes measured

Conditions

Ulcerative Colitis

Explore related trials

Ulcerative Colitis

Where it's being run

57 sites across 45 states
Seoul Teugbyeolsi4
California2
Pennsylvania2
Belgium2
Alberta2
Zhejiang2
Attica2
Beograd2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

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

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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:

Exclusion

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 hernia repair, cholecystectomy, intestinal resection).
Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.

What this trial measures

  • PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)At Week 64

    Maximum observed plasma concentration (Cmax)

  • PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)At Week 64

    Maximum observed plasma concentration (Cmax)

  • PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)At Week 64

    Time to maximum plasma concentration (Tmax)

  • PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)At Week 64

    Time to maximum plasma concentration (Tmax)

  • PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)At Week 64

    Area under the serum concentration-time curve over the dosing interval (AUCtau)

  • PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)At Week 64

    Area under the serum concentration-time curve over the dosing interval (AUCtau)

  • Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMSAt Week 64

    Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1

  • Number of Participants With Adverse EventsUp to 292 Weeks

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related