Clinical trial NCT02982005: A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: KHK4827 (brodalumab)
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks


Eligibility criteria: Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations
* Subject scheduled to undergo a surgical intervention during the study period
* Subject has any active infection or history of infections as defined in the study protocol
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject has not stopped using certain psoriasis therapies as defined in the study protocol
* Subject has previously used any anti-IL-17 biologic therapy
* Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study
* Women of child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational product.
* Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or at baseline
* Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline
* Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Subject has known history of alcohol and/or substance abuse within the last 12 months"

Primary outcomes:
measure: Psoriasis area and severity index (PASI) 75 response
timeFrame: at week 12
measure: Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"
timeFrame: at week 12
Secondary outcomes:
measure: PASI 50/75/90/100 response by visit
timeFrame: Baseline to week 64
measure: sPGA of "0 (clear) or 1 (almost clear)" by visit
timeFrame: Baseline to week 64
measure: Body surface area (BSA) involvement of lesion
timeFrame: Baseline to week 64
measure: Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)
timeFrame: Baseline to week 64
measure: Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)
timeFrame: Baseline to week 64
measure: Dermatology life quality index (DLQI)
timeFrame: Baseline to week 64
measure: Treatment-emergent adverse events (TEAEs) or drug-related TEAEs
timeFrame: Baseline to week 64
measure: Laboratory values
timeFrame: Baseline to week 64
measure: Vital signs
timeFrame: Baseline to week 64
measure: Anti-KHK4827 antibodies
timeFrame: Baseline, Week 12, Week 24, Week 48, Week 64
measure: Serum KHK4827 concentration
timeFrame: Baseline, Week 8, Week 10, Week 12, Week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea, Republic of
Study officials:
References: