A Phase 4 Clinical Study of Brodalumab

An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

This study [4827-005 (post market)] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed Study 4827-003 (Study 003) and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris; Psoriatic Arthritis; Pustular; Psoriasis, Palmaris Et Plantaris; Psoriatic Erythroderma
• Intervention / Treatment: Drug: Brodalumab 210mg SC

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • The Jikei University Scoole of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has voluntarily signed the written informed consent form to participate in this study
• Subject has completed the study 4827-005 (phase 3)

Exclusion Criteria:

• Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
• Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Brodalumab 210mg SC; Brodalumab 210mg subcutaneous injection	Drug: Brodalumab 210mg SC; 210 mg, subcutaneous dosing, every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and types of adverse events and adverse reactions	28 weeks
Anti-KHK4827 antibody	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.		28 weeks
Change in body surface area involvement (BSA) of lesion		28 weeks
Clinical Global Impression (CGI)		28 weeks
American College of Rheumatology (ACR) 20		28 weeks
Serum KHK4827 concentration		28 weeks
Percent improvement in PASI		28 weeks
PASI 50, 75, 90, and 100		28 weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"		28 weeks
sPGA of "0 (clear)"		28 weeks
Pustular symptom score	This score indicate the severity of generalized pustular psoriasis (GPP). The severity of GPP (0:none-3:severe) is classified as mild(1), moderateor(2) severe(3) based on a total score after rating skin symptoms (erythema, pustules and edema) and systemic inflammation accom-panied by certain laboratory findings (fever, white blood cellcount, and serum CRP and albumin levels).	28 weeks

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2016
• Primary Completion (ACTUAL): January 10, 2017
• Study Completion (ACTUAL): July 24, 2017

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (ACTUAL): December 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Dermatitis; Skin Diseases, Eczematous; Spondylarthropathies; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic; Dermatitis, Exfoliative; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: 4827-005 (post market)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No