NCT04183881

CompletedPhase 4

A Phase 4 Clinical Study of Brodalumab

Kyowa Kirin Co., Ltd.Source

Compare

Other study identifiers

Sponsor study identifier

4827-005 (post market)

Study Type

interventional

Actual enrollment (reported)

138

Locations

1 country

Sites

1

Timeline

Study Start

July 4, 2016

Actual (reported)

Primary Completion

January 10, 2017

Actual (reported)

Study Completion

July 24, 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 138 participants
Study completion date: July 24, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 4, 2016
Actual (reported)
Primary Completion
January 10, 2017
Actual (reported)
Study Completion
July 24, 2017
Actual (reported)
First Submitted
November 29, 2019
Actual (reported)
First Posted
December 3, 2019
Actual (reported)

Last Updated: December 9, 2019
Status Verified: December 2019
Last Update Submitted: December 5, 2019

Conditions

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

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (10)

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
PASI 50, 75, 90, and 100
28 weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
28 weeks
sPGA of "0 (clear)"
28 weeks
+5 more secondary outcomes

Study Arms (1)

Brodalumab 210mg SC

EXPERIMENTAL

Brodalumab 210mg subcutaneous injection

Drug: Brodalumab 210mg SC

Interventions

Brodalumab 210mg SCDrug

210 mg, subcutaneous dosing, every 2 weeks

Brodalumab 210mg SC

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject has voluntarily signed the written informed consent form to participate in this study
Subject has completed the study 4827-005 (phase 3)

You may not qualify if:

Sponsors & Collaborators

Kyowa Kirin Co., Ltd.
Industrylead

Study Sites (1)

The Jikei University Scoole of Medicine

Tokyo, Japan

MeSH Terms

Conditions

Arthritis, PsoriaticPsoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Enrollment

138 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 3, 2019

Study Start

July 4, 2016

Actual (reported)

NCT04622033

Brodalumab in Palmoplantar Psoriasis

Phase 4Unknown

NCT03331835

A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis

Phase 4Completed

NCT02024646

Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis

Phase 3Completed

NCT02029495

Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis

Phase 3Terminated

NCT02985983

A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)

Phase 3Completed

NCT04533737

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Phase 4Terminated

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

Contact the study team to confirm eligibility.

Primary Completion

January 10, 2017

Actual (reported)

Study Completion

July 24, 2017

Actual (reported)

Last Updated

December 9, 2019

Record last verified: 2019-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04183881
Data provider: ClinicalTrials.gov
Source updated: 2019-12-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:06 UTC

Locations

JP(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (1)

Brodalumab 210mg SC

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations