A Phase 2 Clinical Study of KHK4827

Phase 2

Completed

• Conditions: Moderate to Severe Plaque Psoriasis
• Interventions: Drug: KHK4827; Drug: Placebo

• Registration Number: NCT01748539
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-03
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KHK4827 140mg SC	KHK4827	-
KHK4827 210mg SC	KHK4827	-
Placebo SC	Placebo	-
KHK4827 70mg SC	KHK4827	-

Primary Outcome Measures

Name	Time	Method
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12	12 weeks

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin; 🇯🇵 Chiyoda-ku, Tokyo, Japan