NCT02052609

Brief Summary

This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2014

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

First Submitted

Initial submission to the registry

January 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2016

Completed
Last Updated

August 25, 2023

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

January 30, 2014

Last Update Submit

August 24, 2023

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 (2)

KHK4827 140mg SC

EXPERIMENTAL
Drug: KHK4827 140mg SC

KHK4827 210mg SC

EXPERIMENTAL
Drug: KHK4827 210mg SC

Interventions

KHK4827 140mg SCDRUG

Experimental1:KHK4827 140mg subcutaneous injection

KHK4827 140mg SC
KHK4827 210mg SCDRUG

Experimental2:KHK4827 210mg subcutaneous injection

KHK4827 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 week 52 evaluation either in Study 003 or 004

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)

For additional information regarding investigative sites for this trial, contact Kyowa Kirin

Chiyoda-ku, Tokyo, 100-8185, 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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 3, 2014

Study Start

February 1, 2014

Primary Completion

January 28, 2015

Study Completion

July 4, 2016

Last Updated

August 25, 2023

Record last verified: 2019-11

Locations

JP(1)