A Phase 4 Clinical Study of Brodalumab

Kyowa Kirin

Status and phase: Completed; Phase 4

Conditions: Pustular; Psoriasis, Palmaris Et Plantaris; Psoriatic Arthritis; Psoriatic Erythroderma; Psoriasis Vulgaris

Treatments: Drug: Brodalumab 210mg SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04183881

4827-005 (post market)

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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138 participants in 1 patient group

Brodalumab 210mg SC

Experimental group

Description:

Brodalumab 210mg subcutaneous injection

Treatment:

Drug: Brodalumab 210mg SC