A Phase 3 Clinical Study of KHK4827 | NCT01782924

Studies
A Phase 3 Clinical Study of KHK4827

NCT01782924

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Feb 16, 2015Estimated

Enrollment

145Actual

Phase

Phase 3

Conditions

Psoriasis

Interventions

KHK4827

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

Feb 2015

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

Mar 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jan 27, 2013

First Submission Date that Met QC Criteria

Jan 31, 2013

First Posted Date

Feb 4, 2013Estimated

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

Feb 12, 2015

Last Update Posted Date

Feb 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 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.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Label	Type	Description	Intervention Names
KHK4827 140mg SC	Experimental		Drug: KHK4827
KHK4827 210mg SC	Experimental		Drug: KHK4827

Name	Type	Description	Arm Group Labels	Other Names
KHK4827	Drug		KHK4827 140mg SC KHK4827 210mg SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

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 week 12 evaluation of Study 4827-002

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/subinvestigators

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

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
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin		Chiyoda-ku	Tokyo	100-8185	Japan

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue 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