- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183881
A Phase 4 Clinical Study of Brodalumab
December 5, 2019 updated by: Kyowa Kirin Co., Ltd.
An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
138
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan
- The Jikei University Scoole of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject has voluntarily signed the written informed consent form to participate in this study
- Subject has completed the study 4827-005 (phase 3)
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/sub investigators
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Brodalumab 210mg SC
Brodalumab 210mg subcutaneous injection
|
210 mg, subcutaneous dosing, every 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and types of adverse events and adverse reactions
Time Frame: 28 weeks
|
28 weeks
|
Anti-KHK4827 antibody
Time Frame: 28 weeks
|
28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
Time Frame: 28 weeks
|
28 weeks
|
|
Change in body surface area involvement (BSA) of lesion
Time Frame: 28 weeks
|
28 weeks
|
|
Clinical Global Impression (CGI)
Time Frame: 28 weeks
|
28 weeks
|
|
American College of Rheumatology (ACR) 20
Time Frame: 28 weeks
|
28 weeks
|
|
Serum KHK4827 concentration
Time Frame: 28 weeks
|
28 weeks
|
|
Percent improvement in PASI
Time Frame: 28 weeks
|
28 weeks
|
|
PASI 50, 75, 90, and 100
Time Frame: 28 weeks
|
28 weeks
|
|
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
Time Frame: 28 weeks
|
28 weeks
|
|
sPGA of "0 (clear)"
Time Frame: 28 weeks
|
28 weeks
|
|
Pustular symptom score
Time Frame: 28 weeks
|
This score indicate the severity of generalized pustular psoriasis (GPP).
The severity of GPP (0:none-3:severe) is classified as mild(1), moderateor(2) severe(3) based on a total score after rating skin symptoms (erythema, pustules and edema) and systemic inflammation accom-panied by certain laboratory findings (fever, white blood cellcount, and serum CRP and albumin levels).
|
28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 4, 2016
Primary Completion (ACTUAL)
January 10, 2017
Study Completion (ACTUAL)
July 24, 2017
Study Registration Dates
First Submitted
November 29, 2019
First Submitted That Met QC Criteria
November 29, 2019
First Posted (ACTUAL)
December 3, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 9, 2019
Last Update Submitted That Met QC Criteria
December 5, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4827-005 (post market)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis Vulgaris
-
LEO PharmaCompletedPlaque Psoriasis | Psoriasis VulgarisGermany
-
SoligenixRecruitingPsoriasis | Plaque Psoriasis | Psoriasis VulgarisUnited States
-
LEO PharmaTerminatedPsoriasis | Plaque Psoriasis | Psoriasis VulgarisBelgium, Germany, Italy, Spain, Denmark, Austria, France, Greece, Switzerland, United Kingdom, Netherlands, Sweden
-
PRCL Research Inc.CompletedPlaque Psoriasis | Psoriasis VulgarisCanada, Slovakia, Ukraine
-
Chinese University of Hong KongNot yet recruitingPsoriasis Vulgaris
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationRecruitingPsoriasis VulgarisUnited States
-
University of California, San FranciscoSun Pharmaceutical Industries LimitedRecruiting
-
Centre for Human Drug Research, NetherlandsJanssen PharmaceuticalsRecruiting
Clinical Trials on Brodalumab 210mg SC
-
Kyowa Kirin Co., Ltd.CompletedPsoriasis Vulgaris | Psoriatic Arthritis | Pustular; Psoriasis, Palmaris Et Plantaris | Psoriatic ErythrodermaJapan
-
MedDerm AssociatesTerminated
-
Bausch Health Americas, Inc.Completed
-
AmgenWithdrawnAxial SpondyloarthritisUnited States, Canada
-
Bausch Health Americas, Inc.TerminatedPsoriasisUnited States, Germany, Poland, Switzerland, France, Canada
-
Bausch Health Americas, Inc.CompletedPsoriatic ArthritisUnited States, France, Hungary, Mexico, Poland, Germany, Canada, Greece, Russian Federation, Latvia
-
Bausch Health Americas, Inc.TerminatedPsoriatic ArthritisUnited States, Italy, Spain, Hungary, Belgium, Mexico, Poland, Switzerland, United Kingdom, Russian Federation, Canada, Greece, France, Bulgaria, Slovakia, Estonia, Czech Republic
-
Bausch Health Americas, Inc.TerminatedModerate to Severe Plaque PsoriasisUnited States, Austria, France, Poland, Australia, Czechia, Canada, Hungary, Portugal, Spain, Netherlands
-
Bausch Health Americas, Inc.TerminatedPlaque PsoriasisUnited States, Belgium, Italy, Hungary, Poland, Australia, France, Greece, Russian Federation, Latvia, Canada
-
Innovent Biologics (Suzhou) Co. Ltd.CompletedHypercholesterolemiaChina