臨床研究等提出・公開システム

[M19-977] A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less Than 18 Years of Age with Moderate to Severe Plaque Psoriasis

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants with Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

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

Not Recruiting

Aug. 21, 2021

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

- Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
- Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the PASI and sPGA.
- Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.

- Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.

Both

Psoriasis

Part 1: Risankizumab Dose A
Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
Participants age 12 to less than 18 will receive:
Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4).
Period B: Risankizumab Dose A or B based on body weight for 24 weeks.
Part 2: Risankizumab Dose A/B
Participants age 12 to less than 18 will receive:
Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare.
Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
Part 3: Risankizumab Dose A/B
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.
Part 4: Risankizumab Dose A/B
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.

- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
- Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear

- Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI):Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
- Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI):Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
- Part 2 (Period C): Percentage of Participants sPGA Clear or Almost Clear:Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)
- Part 2 (Period C): Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI):Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
- Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI):Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
- Part 2 (Period C): Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI):Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
- Part 2 (Period C): Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI):Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
- Part 2 (Period A): Change in Family Dermatology Life Quality Index (FDLQI):Baseline (Week 0) to Week 16 in Part 2 (Period A)
- Part 2 (Period C): Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI):Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
- Part 2 (Period A): Change in Children's Dermatology Life Quality Index (CDLQI):Baseline (Week 0) to Week 16 in Part 2 (Period A)
- Part 2 (Period C): Change in FDLQI:Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
- Part 2 (Period C): Change in CDLQI:Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)

+81-72-804-2808

July. 20, 2021

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.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

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