A Phase 4 Clinical Study of Brodalumab

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04183881
• Date of registration: 29/11/2019
• Prospective Registration: No
• Primary sponsor: Kyowa Kirin Co., Ltd.
• Public title: A Phase 4 Clinical Study of Brodalumab
• Scientific title: An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
• Date of first enrolment: July 4, 2016
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04183881
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriatic Erythroderma

Psoriatic Arthritis

Psoriasis Vulgaris

Pustular; Psoriasis, Palmaris Et Plantaris

Intervention(s)

Drug: Brodalumab 210mg SC

Primary Outcome(s)

Anti-KHK4827 antibody [Time Frame: 28 weeks]

Incidence and types of adverse events and adverse reactions [Time Frame: 28 weeks]

Secondary Outcome(s)

Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study. [Time Frame: 28 weeks]

Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)" [Time Frame: 28 weeks]

Pustular symptom score [Time Frame: 28 weeks]

sPGA of "0 (clear)" [Time Frame: 28 weeks]

PASI 50, 75, 90, and 100 [Time Frame: 28 weeks]

Percent improvement in PASI [Time Frame: 28 weeks]

American College of Rheumatology (ACR) 20 [Time Frame: 28 weeks]

Change in body surface area involvement (BSA) of lesion [Time Frame: 28 weeks]

Clinical Global Impression (CGI) [Time Frame: 28 weeks]

Serum KHK4827 concentration [Time Frame: 28 weeks]

Secondary ID(s)

4827-005 (post market)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors