2023-504156-10-00CompletedPhase 3
OptIMMize-1: 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
Abbvie Deutschland GmbH & Co. KG16 sites in 3 countries72 target enrollmentStarted: July 14, 2023Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 72
- Locations
- 16
- Primary Endpoint
- Co-primary Endpoints: - Achievement of PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 16 of initial treatment.
Study Overview
Brief Summary
The objective of this study is to evaluate the PK, safety, and efficacy of risankizumab in subjects from 6 to less than 18 years of age with moderate to severe plaque Ps. The hypothesis corresponding to the primary objective is that the safety and efficacy of treatment with risankizumab for moderate to severe Ps in the pediatric population is similar to the response observed in the adult population.
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- Yes
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
- •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.
Outcomes
Primary Outcomes
Co-primary Endpoints: - Achievement of PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 16 of initial treatment.
Co-primary Endpoints: - Achievement of PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 16 of initial treatment.
Achievement of sPGA clear or almost clear (0 or 1) at Week 16 of initial treatment
Achievement of sPGA clear or almost clear (0 or 1) at Week 16 of initial treatment
Secondary Outcomes
- Ranked Secondary Endpoints: Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 16 of initial treatment.
- Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 16 of initial treatment.
- Achievement of sPGA clear or almost clear at (0 or 1) at Week 0 and Week 16 of the retreatment phase in Part 2.
- Non-ranked Secondary Efficacy Endpoints: Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 16 of initial treatment
- Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 0 and Week 16 of the re-treatment phase in Part 2.
- Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2.
- Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2.
- Achievement of a PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2
- Change in Children's Dermatology Life Quality Index (CDLQI) from Week 0 to Week 16 of initial treatment in Part 2
- Change in CDLQI from Week 0 to Week 16 of re-treatment phase of Part 2
- Change in Family Dermatology Life Quality Index (FDLQI) from Week 0 to Week 16 of initial treatment in Part 2
- Change in FDLQI from Week 0 to Week 16 of re-treatment phase of Part 2
- Change in Itch Numerical Rating Scale (Itch NRS) from Week 0 to Week 16 of initial treatment in Part 2
- Change in Itch NRS from Week 0 to Week 16 of re-treatment phase in Part 2
- Achievement of ≥ 4-point improvement from baseline in the Itch Numerical Rating Scale (in patients with Baseline score ≥ 4) at Week 16 of initial treatment in Part 2
Investigators
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
Study Sites (16)
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