A Phase 2 Clinical Study of KHK4827

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

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 Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: KHK4827

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KHK4827 70mg SC	Drug: KHK4827
Experimental: KHK4827 140mg SC	Drug: KHK4827
Experimental: KHK4827 210mg SC	Drug: KHK4827
Placebo Comparator: Placebo SC	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2013
• Last Update Submitted That Met QC Criteria: September 3, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: 4827-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No