A Phase 4 Clinical Study of Brodalumab

Psoriatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183881
• Other study ID #: 4827-005 (post market)
• Status: Completed
• Phase: Phase 4
• Start date: July 4, 2016
• Est. completion date: July 24, 2017

Study information

• Verified date: December 2019
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 24, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Dermatitis, Exfoliative
• Psoriasis
• Psoriasis Vulgaris
• Psoriatic Arthritis
• Psoriatic Erythroderma
• Pustular; Psoriasis, Palmaris Et Plantaris

Intervention

Drug:
• Brodalumab 210mg SC
210 mg, subcutaneous dosing, every 2 weeks

Locations

Country	Name	City	State
Japan	The Jikei University Scoole of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and types of adverse events and adverse reactions		28 weeks
Primary	Anti-KHK4827 antibody		28 weeks
Secondary	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
Secondary	Percent improvement in PASI		28 weeks
Secondary	PASI 50, 75, 90, and 100		28 weeks
Secondary	Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"		28 weeks
Secondary	sPGA of "0 (clear)"		28 weeks
Secondary	Change in body surface area involvement (BSA) of lesion		28 weeks
Secondary	Clinical Global Impression (CGI)		28 weeks
Secondary	American College of Rheumatology (ACR) 20		28 weeks
Secondary	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
Secondary	Serum KHK4827 concentration		28 weeks