A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Moderate to Severe Plaque Psoriasis

The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 49241
    • Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 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 involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline

Exclusion Criteria:

• Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations
• Subject scheduled to undergo a surgical intervention during the study period
• Subject has any active infection or history of infections as defined in the study protocol
• Subject has known history of Crohn's disease
• Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
• Subject has not stopped using certain psoriasis therapies as defined in the study protocol
• Subject has previously used any anti-IL-17 biologic therapy
• Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study
• Women of child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational product.
• Subject has known history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or at baseline
• Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline
• Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Subject has known history of alcohol and/or substance abuse within the last 12 months"

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered SC	Drug: Placebo; Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.
Experimental: KHK4827; KHK4827 administered SC	Drug: KHK4827; Administered KHK4827 by subcutaneous (SC) injection until week 62.; Other Names: Brodalumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Psoriasis area and severity index (PASI) 75 response	at week 12
Static physician's global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"	at week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
PASI 50/75/90/100 response by visit	Baseline to week 64
sPGA of "0 (clear) or 1 (almost clear)" by visit	Baseline to week 64
Body surface area (BSA) involvement of lesion	Baseline to week 64
Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)	Baseline to week 64
Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)	Baseline to week 64
Dermatology life quality index (DLQI)	Baseline to week 64
Treatment-emergent adverse events (TEAEs) or drug-related TEAEs	Baseline to week 64
Laboratory values	Baseline to week 64
Vital signs	Baseline to week 64
Anti-KHK4827 antibodies	Baseline, Week 12, Week 24, Week 48, Week 64
Serum KHK4827 concentration	Baseline, Week 8, Week 10, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Kyowa Kirin Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): August 14, 2018
• Study Completion (Actual): August 14, 2018

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 9, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: KHK4827 (brodalumab)
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: 4827-KR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No