NCT01748539CompletedPhase 2
A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12
Study Overview
Brief Summary
This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 70 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 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.
- •Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.
Exclusion Criteria
- •Subject diagnosed with erythrodermic psoriasis, pustular 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 investigational product 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 the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus
- •, topical vitamin A, activated form D3 or activated form D3 analogue preparations, weak through strong topical steroids (excluding application on the scalp, axillae, and groin)
- •Subject has used the following therapies within 28 days of the first dose: any other systemic psoriasis therapy (eg, vitamin A, calcineurin inhibitors, methotrexates, steroids), UVA therapy (with or without psoralen), very strong or strongest topical steroid, tar therapy
- •Subject has used the following therapies within 3 months of the first dose: adalimumab, etanercept, infliximab, or live vaccines
- •Subject has used ustekinumab within 6 months of the first dose
- •Subject has previously used an anti-interleukin-17 biologic therapy
Arms & Interventions
KHK4827 70mg SC
Experimental
Intervention: KHK4827 (Drug)
KHK4827 140mg SC
Experimental
Intervention: KHK4827 (Drug)
KHK4827 210mg SC
Experimental
Intervention: KHK4827 (Drug)
Placebo SC
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12
Time Frame: 12 weeks
Secondary Outcomes
- PASI 75 at Week 12(12 Weeks)
- PASI 50, 90 and 100 at Week 12(12 weeks)
- Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12(12 Weeks)
- sPGA of "clear (0)" at Week 12(12 weeks)
- Body surface area involvement (BSA) of lesion at Week 12(12 weeks)
- American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12(12 weeks)
- Incidence and types of adverse events and adverse reactions(12 weeks)
- Profiles of Pharmacokinetics(12 weeks)
Investigators
Study Sites (1)
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