A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
NCT ID: NCT07071519
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2025-07-28
2034-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Expansion Cohort 3: SS1
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.
Risankizumab
Risankizumab intravenous (IV) infusion
Expansion Cohort 3: SS2 Dose B
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
Expansion Cohort 3: SS3 Dose A
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
Expansion Cohort 3: SS3 Dose B
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
Expansion Cohort 3: SS2 Dose A
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
PK Cohort 2: SS3 Dose B
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
PK Cohort 1: SS1
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
Risankizumab
Risankizumab intravenous (IV) infusion
PK Cohort 1: SS2 Dose A
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
PK Cohort 1: SS2 Dose B
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
PK Cohort 1: SS3 Dose A
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
PK Cohort 1: SS3 Dose B
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
PK Cohort 2: SS1
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.
Risankizumab
Risankizumab intravenous (IV) infusion
PK Cohort 2: SS2 Dose A
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
PK Cohort 2: SS2 Dose B
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
PK Cohort 2: SS3 Dose A
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.
Risankizumab
Risankizumab subcutaneous (SC) injection
Interventions
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Risankizumab
Risankizumab intravenous (IV) infusion
Risankizumab
Risankizumab subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
2 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Phoenix Children's Hospital /ID# 273015
Phoenix, Arizona, United States
Childrens Center For Digestive Health Care /ID# 273228
Atlanta, Georgia, United States
Patewood Medical Campus /ID# 272477
Greenville, South Carolina, United States
Cliniques Universitaires UCL Saint-Luc /ID# 270123
Brussels, Brussels Capital, Belgium
Universitaetsklinikum Muenster /ID# 271898
Münster, North Rhine-Westphalia, Germany
General Hospital of Thessaloniki Hippokrateio /ID# 271939
Thessaloniki, , Greece
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 271895
Naples, Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 272967
Rome, Roma, Italy
Ospedale Infantile Burlo Garofolo /ID# 274442
Trieste, , Italy
University Children's Hospital /ID# 269960
Belgrade, Beograd, Serbia
Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
Belgrade-Vračar, Beograd, Serbia
Institute for Child and Youth Health Care of Vojvodina /ID# 269961
Novi Sad, , Serbia
Pusan National University Yangsan Hospital /ID# 272769
Yangsan, Gyeongsangnam-do, South Korea
Seoul National University Hospital /ID# 272852
Seoul, Seoul Teugbyeolsi, South Korea
Kangbuk Samsung Hospital /ID# 273333
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 272894
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 272862
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
Majadahonda, Madrid, Spain
National Taiwan University Hospital /ID# 269244
Taipei City, Taipei, Taiwan
Taichung Veterans General Hospital /ID# 269242
Taichung, , Taiwan
Countries
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Central Contacts
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Related Links
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Related Info
Other Identifiers
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M19-751
Identifier Type: -
Identifier Source: org_study_id