臨床研究等提出・公開システム

[M19-751]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

[M19-751]A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

Fujimura Kimino

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

Aug. 31, 2026

Interventional

randomized controlled trial

double blind

historical control

parallel assignment

treatment purpose

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.

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.

Ulcerative Colitis

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 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 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 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 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 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 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 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 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 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 subcutaneous (SC) injection

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 intravenous (IV) infusion

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 subcutaneous (SC) injection

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 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 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 subcutaneous (SC) injection

PK Cohort 1 and Cohort 2
- Cmax
- Tmax
- AUCtau

Expansion Cohort 3:
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

PK Cohort1 and Cohort2
Achievement of clinical remission per mMS at Week 64 among Week 12 responders per mMS
Achievement of clinical remission per mMS at Week 12
Achievement of clinical response per mMS at Week 12
Achievement of endoscopic improvement at Week 12
Symptomatic response per partial mMS at Week 12
Achievement of clinical response per mMS at Week 64 among Week 12 responders per mMS
Achievement of endoscopic improvement at Week 64 among Week 12 responders per mMS
Achievement of corticosteroid free clinical remission per mMS at Week 64 among Week 12 responders per mMS

Expansion Cohort 3
Achievement of clinical remission per mMS at Week 12
Achievement of clinical response per mMS at Week 12
Achievement of endoscopic improvement at Week 12
Symptomatic response per partial mMS at Week 12
Achievement of clinical response per mMS at Week 64 among Week 12 responders per mMS
Achievement of endoscopic improvement at Week 64 among Week 12 responders per mMS
Achievement of corticosteroid free clinical remission per mMS at Week 64 among Week 12 responders per mMS.

May. 13, 2026

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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