NCT01782924

Brief Summary

This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2013

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 27, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

January 27, 2013

Last Update Submit

February 12, 2015

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

  • Incidence and types of adverse events and adverse reactions

    52 weeks

  • Laboratory values and vital signs

    52 weeks

  • Development of anti-KHK4827 antibody

    52 weeks

Secondary Outcomes (7)

  • Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)

    52 weeks

  • A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response

    52 weeks

  • Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"

    52 weeks

  • sPGA of "clear (0)"

    52 weeks

  • Body surface area involvement (BSA) of lesion

    52 weeks

  • +2 more secondary outcomes

Study Arms (2)

KHK4827 140mg SC

EXPERIMENTAL
Drug: KHK4827

KHK4827 210mg SC

EXPERIMENTAL
Drug: KHK4827

Interventions

KHK4827DRUG
KHK4827 140mg SCKHK4827 210mg SC

Eligibility Criteria

Age20 Years - 70 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 12 evaluation of Study 4827-002

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/subinvestigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chiyoda-ku, Tokyo, 100-8185, Japan

Location

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2013

First Posted

February 4, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

JP(1)