Clinical trial NCT01782937: An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis
Official title: A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Subject has signed voluntarily the written informed consent form to participate in this study.
* Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma.
* Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.

Exclusion Criteria:

* Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion \< 80% at baseline.
* Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis.
* Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of KHK4827 on psoriasis.
* Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
* Subject has used Ultra Violet B (UVB) therapy within 14 days of the first dose or Ultra Violet A (UVA) (with or without psoralen) within 28 days of the first dose.
* Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively.
* Subject has stopped ustekinumab or other anti-Interleukin (IL)-23 biologics therapy due to lack of efficacy
* Subject has used live vaccine within 3 months of the first dose
* Subject has previously used an anti-IL-17 biologic therapy

Primary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: 52 weeks
Secondary outcomes:
measure: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
timeFrame: 52 weeks
measure: American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
timeFrame: 52 weeks
measure: Pustular symptom score (only in subjects with pustular psoriasis)
timeFrame: 52 weeks
measure: Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma)
timeFrame: 52 weeks
measure: sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)
timeFrame: 52 weeks
measure: Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)
timeFrame: 52 weeks
measure: Incidence and types of adverse events and adverse reactions
timeFrame: 52 weeks
measure: Laboratory values and vital signs
timeFrame: 52 weeks
measure: Profiles of pharmacokinetics
timeFrame: 52 weeks
measure: Development of anti-KHK4827 antibody
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Chiyoda-ku
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
state: Tokyo
Study officials:
References: