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A Phase 4 Clinical Study of Brodalumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04183881
Recruitment Status : Completed
First Posted : December 3, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Psoriatic Arthritis Pustular; Psoriasis, Palmaris Et Plantaris Psoriatic Erythroderma Drug: Brodalumab 210mg SC Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Actual Study Start Date : July 4, 2016
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : July 24, 2017


Arm Intervention/treatment
Experimental: Brodalumab 210mg SC
Brodalumab 210mg subcutaneous injection
Drug: Brodalumab 210mg SC
210 mg, subcutaneous dosing, every 2 weeks




Primary Outcome Measures :
  1. Incidence and types of adverse events and adverse reactions [ Time Frame: 28 weeks ]
  2. Anti-KHK4827 antibody [ Time Frame: 28 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Percent improvement in PASI [ Time Frame: 28 weeks ]
  3. PASI 50, 75, 90, and 100 [ Time Frame: 28 weeks ]
  4. Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)" [ Time Frame: 28 weeks ]
  5. sPGA of "0 (clear)" [ Time Frame: 28 weeks ]
  6. Change in body surface area involvement (BSA) of lesion [ Time Frame: 28 weeks ]
  7. Clinical Global Impression (CGI) [ Time Frame: 28 weeks ]
  8. American College of Rheumatology (ACR) 20 [ Time Frame: 28 weeks ]
  9. 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).

  10. Serum KHK4827 concentration [ Time Frame: 28 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183881


Locations
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Japan
The Jikei University Scoole of Medicine
Tokyo, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT04183881    
Other Study ID Numbers: 4827-005 (post market)
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Psoriasis
Dermatitis, Exfoliative
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Dermatitis
Skin Diseases, Eczematous
Brodalumab
Dermatologic Agents