Phase 3
N=17
A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03022045 ↗Enrolled (actual)
17
Serious AEs
23.5%
Results posted
Feb 2019
Primary outcome: Primary: Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 — 100; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- risankizumab (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 |
100; 100 | — |
| PRIMARY Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 |
100; 100 | — |
| SECONDARY Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52 |
— | — |
| SECONDARY Percentage of Participants With EP Achieving EP Clinical Response at Week 52 |
— | — |
| SECONDARY Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 |
100; 75 | — |
| SECONDARY Percentage of Participants With EP Achieving PASI90 at Week 16 |
60; 100 | — |
| SECONDARY Percentage of Participants With GPP Achieving PASI90 at Week 52 |
— | — |
| SECONDARY Percentage of Participants With EP Achieving PASI90 at Week 52 |
— | — |
Summary
The purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).
Eligibility Criteria
Inclusion Criteria
For GPP
- Have a diagnosis of GPP for at least 60 days prior to informed consent based on the diagnostic criteria of the Japanese Dermatological Association (JDA). Subjects not fulfilling one of the diagnostic criteria i.e., "accompanying systemic symptoms including fever or malaise" at the time of screening can be entered.
- Subjects with an erythema area with pustules accounting for ≥ 10% of the body surface area (BSA), and with a severity assessment criteria score (JDA total score) specified by the JDA of less than 14.
- Must be candidates for systemic therapy or phototherapy for GPP, as assessed by the investigator.
For EP
- Have a diagnosis of EP prior to informed consent.
- Subjects with an inflammatory erythema area accounting for ≥ 80% of the BSA at screening and at the time of the first administration of the study drug.
- Must be candidates for systemic therapy or phototherapy for EP, as assessed by the investigator.
Exclusion Criteria
- Previous exposure to risankizumab.
- Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted).
For GPP
- Subjects with active ongoing inflammatory diseases other than GPP that might confound trial evaluations according to investigator's judgment.
For EP
- Subjects with active ongoing inflammatory diseases other than EP that might confound trial evaluations according to investigator's judgment.
- Subject diagnosed with medication-induced or medication-exacerbated EP.
Data sourced from ClinicalTrials.gov (NCT03022045). 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.