A Phase 2 Clinical Study of KHK4827

NCT ID: NCT01748539

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-09-30

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.

Conditions

Moderate to Severe Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KHK4827 70mg SC

Group Type: EXPERIMENTAL

KHK4827

Intervention Type: DRUG

KHK4827 140mg SC

Group Type: EXPERIMENTAL

KHK4827

Intervention Type: DRUG

KHK4827 210mg SC

Group Type: EXPERIMENTAL

KHK4827

Intervention Type: DRUG

Placebo SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

KHK4827

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Chiyoda-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 26547109 (View on PubMed)

Other Identifiers

4827-002

Identifier Type: -

Identifier Source: org_study_id