Phase 3 N=12 Randomized Single-blind Treatment

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

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT04435600 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

May 2025

Primary outcome: Primary: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) — 83.3; 85.7; 85.2; 92.3 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Risankizumab (Drug); Ustekinumab (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: AbbVie
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)	83.3; 85.7; 85.2; 92.3; 86.7	—
PRIMARY Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)	83.3; 75.0; 79.6; 84.6; 90.0	—
PRIMARY Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline	0.0; 62.5	—
SECONDARY Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)	37.5; 87.5	—
SECONDARY Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)	0; 25.0	—
SECONDARY Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)	12.5; 62.5	—
SECONDARY Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline	0.0; 62.5	—
SECONDARY Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)	75.0; 87.5	—
SECONDARY Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)	75.0; 87.5	—
SECONDARY Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)	37.5; 87.5	—
SECONDARY Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)	0; 25.0	—
SECONDARY Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)	37.5; 87.5	—
SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score	-7.5	—
SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score	-7.5	—
SECONDARY Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score	-5.8	—
SECONDARY Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score	-5.8	—
SECONDARY Change From Baseline in Itch Numerical Rating Scale (Itch NRS)	-2.8	—
SECONDARY Change From Baseline in Itch Numerical Rating Scale (Itch NRS)	-2.8	—
SECONDARY Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4)	57.1; 64.9	—

Summary

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms. Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts. Part 1: Participants aged 12 18 will receive risankizumab based on body weight). Around 132 participants will be enrolled in approximately 50 sites worldwide. Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection. Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks. Part 2: * Period A: Risankizumab or ustekinumab for 16 weeks. * Period B: Risankizumab or no treatment for 36 weeks. * Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks. There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.

Eligibility 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 Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04435600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.