臨床研究等提出・公開システム

[M16-194] A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab with Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) with Moderately to Severely Active Crohn's Disease

[M16-194] 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

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

Mar. 10, 2025

Interventional

randomized controlled trial

double blind

historical control

parallel assignment

treatment purpose

- 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, oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies

- History of 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:
a. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
b. A diagnosis of CD prior to 2 years of age.
c. A diagnosis or suspected diagnosis of a primary immunodeficiency.
d. Currently known complications of CD such as:
- 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.
e. Ostomy or ileoanal pouch.
f. Diagnosis of short gut or short bowel syndrome.
g. 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.

Both

Crohn's disease

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 subjects who complete SS1 are eligible to enter SS2.
Drug: Risankizumab Intravenous (IV) Infusion

PK Cohort 1: SS2
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 or Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-termextension SS3.
Drug: Risankizumab Subcutaneous (SC) Injection

PK Cohort 1: SS3
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.
Drug: 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.
Drug: Risankizumab Intravenous (IV) Infusion

PK Cohort 2: SS2
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 or Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-termextension SS3.
Drug: Risankizumab Subcutaneous (SC) Injection

PK Cohort 2: SS3
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.
Drug: 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 subjects who complete SS1 are eligible to enter SS2.
Drug: Risankizumab Intravenous (IV) Infusion

Expansion Cohort 3: SS2
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 either double-blind risankizumab Dose A or Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-termextension SS3.
Drug: Risankizumab Subcutaneous (SC) Injection

Expansion Cohort 3: SS3
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.
Drug: Risankizumab Subcutaneous (SC) Injection

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

Expansion Cohort 3
- Achievement of clinical remission per PCDAI at Week 64 (SS2)
- Achievement of endoscopic response at Week 64 (SS2)

PK Cohort 1 and Cohort 2
- Achievement of clinical remission per PCDAI at Week 64 (SS2).
- Achievement of endoscopic response at Week 64 (SS2).
- Achievement of clinical remission per PCDAI at Week 12 (SS1).
- Achievement of endoscopic response at Week 12 (SS1).
- Achievement of endoscopic remission at Week 12 (SS1).
- Achievement of endoscopic remission at Week 64 (SS2).
- Achievement of corticosteroid-free clinical remission per PCDAI at Week 64 (SS2).

Expansion Cohort 3
- Achievement of clinical remission per PCDAI at Week 12 (SS1).
- Achievement of endoscopic response at Week 12 (SS1).
- Achievement of endoscopic remission at Week 12 (SS1).
- Achievement of endoscopic remission at Week 64 (SS2).
- Achievement of corticosteroid-free clinical remission per PCDAI at Week 64 (SS2).

+81-3-5494-7297

Nov. 13, 2024

Nov. 13, 2024

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Nov. 13, 2024

Nov. 13, 2024

Nov. 13, 2024

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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