A Phase 4 Clinical Study of Brodalumab | NCT04183881

Studies
A Phase 4 Clinical Study of Brodalumab

NCT04183881

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Dec 9, 2019Actual

Enrollment

138Actual

Phase

Phase 4

Conditions

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

Interventions

Brodalumab 210mg SC

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2016Actual

Primary Completion Date

Jan 10, 2017Actual

Completion Date

Jul 24, 2017Actual

First Submitted Date

Nov 29, 2019

First Submission Date that Met QC Criteria

Nov 29, 2019

First Posted Date

Dec 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2019

Last Update Posted Date

Dec 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brodalumab 210mg SC	Experimental	Brodalumab 210mg subcutaneous injection	Drug: Brodalumab 210mg SC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brodalumab 210mg SC	Drug	210 mg, subcutaneous dosing, every 2 weeks	Brodalumab 210mg SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and types of adverse events and adverse reactions		28 weeks
Anti-KHK4827 antibody		28 weeks

Secondary Outcomes

Measure	Description	Time Frame
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
Percent improvement in PASI		28 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Jikei University Scoole of Medicine		Tokyo			Japan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015535	Arthritis, Psoriatic
D011565	Psoriasis

Ancestor Terms

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C571216	brodalumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided