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

[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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051210069

Enrollment

132

Registered

2021-08-21

Start date

2021-11-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
- 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	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

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Countries

Canada, Germany, Japan, Poland, Spain, United Kingdom, United States

Contacts

Public ContactPatients and HCP Contact for

AbbVie G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026