A Phase 2 Clinical Study of KHK4827

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748539
• Other study ID #: 4827-002
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2012
• Last updated: September 3, 2013
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• KHK4827

• Placebo

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin	Chiyoda-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12		12 weeks	No
Secondary	PASI 75 at Week 12		12 Weeks	No
Secondary	PASI 50, 90 and 100 at Week 12		12 weeks	No
Secondary	Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12		12 Weeks	No
Secondary	sPGA of "clear (0)" at Week 12		12 weeks	No
Secondary	Body surface area involvement (BSA) of lesion at Week 12		12 weeks	No
Secondary	American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12		12 weeks	No
Secondary	Incidence and types of adverse events and adverse reactions		12 weeks	Yes
Secondary	Profiles of Pharmacokinetics		12 weeks	No