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Taking people in ItalyPhase 3

Tests risankizumab in children and teens with ulcerative colitis

Tests risankizumab in children aged 2 to 17 with moderate to severe ulcerative colitis.

Key facts

Who runs it
AbbVie
Where
Naples, Rome, San Giovanni Rotondo, and Trieste, ItalySee the 4 sitesAlso in 15 other countries, 71 sites
Registry title
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Status
Recruiting
Phase
Phase 3
People taking part
120 people, planned
Started
28 Jul 2025
Expected to end
Jul 2034
Type of study
Interventional, 15 groups
Treatments tested
  • Risankizumab
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 2 to under 18 with moderately to severely active ulcerative colitis, to study how risankizumab works in the body and how safe it is.

Age
2 to under 18 years (17 years at most)
Sex
All sexes can join.
Disease stage
Active ulcerative colitis, with a modified Mayo Score of 5 to 9 points and an endoscopic subscore of 2 to 3, confirmed by a central reader. Ulcerative colitis must be documented for at least 3 months before the start, confirmed by colonoscopy.
Earlier treatment
Must have had side effects (intolerance) or too little response to one or more of these drug types: aminosalicylates, oral locally acting corticosteroids, systemic steroids, immunomodulators, and/or biologic therapies.

Main reasons for not taking part

  • Major surgery within 12 weeks before the start, or planned during the study
  • Another serious medical condition that could interfere with the study or put the child at risk
  • A current infection, colonic dysplasia or cancer in the colon must be ruled out

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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 failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol
  • Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 17 years old?

Where in Italy

Also in 15 other countries, 71 sites

  • Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
  • Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo GarofoloTrieste, ItalyTaking people

About the trial

What the trial wants to find out

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.

Read full original descriptionShow less

Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC 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 maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 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.

The 15 groups in the trial

  • PK Cohort 1: SS1Treatment being tested

    Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2

    Treatment: Risankizumab

  • PK Cohort 1: SS2 Dose ATreatment being tested

    Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.

    Treatment: Risankizumab

  • PK Cohort 1: SS2 Dose BTreatment being tested

    Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.

    Treatment: Risankizumab

  • PK Cohort 1: SS3 Dose ATreatment being tested

    Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

    Treatment: Risankizumab

  • PK Cohort 1: SS3 Dose BTreatment being tested

    Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

    Treatment: Risankizumab

  • PK Cohort 2: SS1Treatment being tested

    Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.

    Treatment: Risankizumab

  • PK Cohort 2: SS2 Dose ATreatment being tested

    Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3.

    Treatment: Risankizumab

  • PK Cohort 2: SS2 Dose BTreatment being tested

    Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3.

    Treatment: Risankizumab

  • PK Cohort 2: SS3 Dose ATreatment being tested

    Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

    Treatment: Risankizumab

  • PK Cohort 2: SS3 Dose BTreatment being tested

    Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

    Treatment: Risankizumab

  • Expansion Cohort 3: SS1Treatment being tested

    Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2.

    Treatment: Risankizumab

  • Expansion Cohort 3: SS2 Dose ATreatment being tested

    Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.

    Treatment: Risankizumab

  • Expansion Cohort 3: SS2 Dose BTreatment being tested

    Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.

    Treatment: Risankizumab

  • Expansion Cohort 3: SS3 Dose ATreatment being tested

    Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

    Treatment: Risankizumab

  • Expansion Cohort 3: SS3 Dose BTreatment being tested

    Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

    Treatment: Risankizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis
Plain-language title
Tests risankizumab in children and teens with ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07071519, who can take part
Record updated
27 October 2026