Clinical trial NCT01748539: A Phase 2 Clinical Study of KHK4827
Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Plaque Psoriasis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: PASI 75 at Week 12
timeFrame: 12 Weeks
measure: PASI 50, 90 and 100 at Week 12
timeFrame: 12 weeks
measure: Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12
timeFrame: 12 Weeks
measure: sPGA of "clear (0)" at Week 12
timeFrame: 12 weeks
measure: Body surface area involvement (BSA) of lesion at Week 12
timeFrame: 12 weeks
measure: American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12
timeFrame: 12 weeks
measure: Incidence and types of adverse events and adverse reactions
timeFrame: 12 weeks
measure: Profiles of Pharmacokinetics
timeFrame: 12 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:
citation: Nakagawa H, Niiro H, Ootaki K; Japanese brodalumab study group. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: Efficacy and safety results from a phase II randomized controlled study. J Dermatol Sci. 2016 Jan;81(1):44-52. doi: 10.1016/j.jdermsci.2015.10.009. Epub 2015 Oct 24.