A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea
Phase 3
Completed
- Conditions
- Moderate to Severe Plaque Psoriasis
- Interventions
- Drug: Placebo
- Registration Number
- NCT02982005
- Lead Sponsor
- Kyowa Kirin Korea Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered SC KHK4827 KHK4827 KHK4827 administered SC
- Primary Outcome Measures
Name Time Method Psoriasis area and severity index (PASI) 75 response at week 12 Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)" at week 12
- Secondary Outcome Measures
Name Time Method Serum KHK4827 concentration Baseline, Week 8, Week 10, Week 12, Week 24 Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline) Baseline to week 64 Laboratory values Baseline to week 64 Vital signs Baseline to week 64 Anti-KHK4827 antibodies Baseline, Week 12, Week 24, Week 48, Week 64 PASI 50/75/90/100 response by visit Baseline to week 64 sPGA of "0 (clear) or 1 (almost clear)" by visit Baseline to week 64 Dermatology life quality index (DLQI) Baseline to week 64 Treatment-emergent adverse events (TEAEs) or drug-related TEAEs Baseline to week 64 Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline) Baseline to week 64 Body surface area (BSA) involvement of lesion Baseline to week 64
Trial Locations
- Locations (1)
Korea, Republic of
🇰🇷Seoul, Korea, Republic of