A Phase 4 Clinical Study of Brodalumab

Phase 4

Completed

• Conditions: Psoriatic Erythroderma; Psoriasis Vulgaris; Pustular; Psoriasis, Palmaris Et Plantaris; Psoriatic Arthritis
• Interventions: Drug: Brodalumab 210mg SC

• Registration Number: NCT04183881
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-04
• Primary Completion: 2017-01-10
• Study Completion: 2017-07-24
• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2019-11-29
• Status Verified: 2019-12
• Study First Posted: 2019-12-03
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brodalumab 210mg SC	Brodalumab 210mg SC	Brodalumab 210mg subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Incidence and types of adverse events and adverse reactions	28 weeks
Anti-KHK4827 antibody	28 weeks

Secondary Outcome Measures

Name	Time	Method
sPGA of "0 (clear)"	28 weeks
Change in body surface area involvement (BSA) of lesion	28 weeks
Percent improvement in PASI	28 weeks
American College of Rheumatology (ACR) 20	28 weeks
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
PASI 50, 75, 90, and 100	28 weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"	28 weeks
Clinical Global Impression (CGI)	28 weeks
Pustular symptom score	28 weeks	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).
Serum KHK4827 concentration	28 weeks

Trial Locations

Locations (1)

The Jikei University Scoole of Medicine; 🇯🇵 Tokyo, Japan