NCT02982005CompletedPhase 3
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
Kyowa Kirin Korea Co., Ltd.1 site in 1 country62 target enrollmentStarted: January 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kyowa Kirin Korea Co., Ltd.
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Psoriasis area and severity index (PASI) 75 response
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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"
Arms & Interventions
KHK4827
Experimental
KHK4827 administered SC
Intervention: KHK4827 (Drug)
Placebo
Placebo Comparator
Placebo administered SC
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Psoriasis area and severity index (PASI) 75 response
Time Frame: at week 12
Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"
Time Frame: at week 12
Secondary Outcomes
- Body surface area (BSA) involvement of lesion(Baseline to week 64)
- 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)
Investigators
Study Sites (1)
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