Plaque Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
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. Are the trial subjects under 18? yes Number of subjects for this age range: 132 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Week 16 of initial treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 Nonranked 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 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 16 of the retreatment phase in Part 2 - Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 0 and 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 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 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.;Timepoint(s) of evaluation of this end point: Week 16 of initial treatment | — |
Countries
Canada, Germany, Japan, Poland, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed