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A Phase 4 Clinical Study of Brodalumab

Primary Purpose

Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Brodalumab 210mg SC
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Jikei University Scoole of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brodalumab 210mg SC

Arm Description

Brodalumab 210mg subcutaneous injection

Outcomes

Primary Outcome Measures

Incidence and types of adverse events and adverse reactions
Anti-KHK4827 antibody

Secondary Outcome Measures

Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
Percent improvement in PASI
PASI 50, 75, 90, and 100
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
sPGA of "0 (clear)"
Change in body surface area involvement (BSA) of lesion
Clinical Global Impression (CGI)
American College of Rheumatology (ACR) 20
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).
Serum KHK4827 concentration

Full Information

First Posted
November 29, 2019
Last Updated
December 5, 2019
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04183881
Brief Title
A Phase 4 Clinical Study of Brodalumab
Official Title
An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 4, 2016 (Actual)
Primary Completion Date
January 10, 2017 (Actual)
Study Completion Date
July 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris, Psoriatic Erythroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brodalumab 210mg SC
Arm Type
Experimental
Arm Description
Brodalumab 210mg subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Brodalumab 210mg SC
Intervention Description
210 mg, subcutaneous dosing, every 2 weeks
Primary Outcome Measure Information:
Title
Incidence and types of adverse events and adverse reactions
Time Frame
28 weeks
Title
Anti-KHK4827 antibody
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
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
Title
Percent improvement in PASI
Time Frame
28 weeks
Title
PASI 50, 75, 90, and 100
Time Frame
28 weeks
Title
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
Time Frame
28 weeks
Title
sPGA of "0 (clear)"
Time Frame
28 weeks
Title
Change in body surface area involvement (BSA) of lesion
Time Frame
28 weeks
Title
Clinical Global Impression (CGI)
Time Frame
28 weeks
Title
American College of Rheumatology (ACR) 20
Time Frame
28 weeks
Title
Pustular symptom score
Description
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).
Time Frame
28 weeks
Title
Serum KHK4827 concentration
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Jikei University Scoole of Medicine
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Phase 4 Clinical Study of Brodalumab

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