NCT04183881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

November 29, 2019

Last Update Submit

December 5, 2019

Conditions

Psoriasis VulgarisPsoriatic ArthritisPustular; Psoriasis, Palmaris Et PlantarisPsoriatic 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:

  • 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.

Sponsors & Collaborators

Study Sites (1)

The Jikei University Scoole of Medicine

Tokyo, Japan

Location

MeSH Terms

Conditions

Arthritis, PsoriaticPsoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

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

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

Primary Completion

January 10, 2017

Study Completion

July 24, 2017

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations

JP(1)