Clinical trial
An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Name
4827-005
Description
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 arms
Trial start
2014-02-01
Estimated PCD
2015-01-28
Trial end
2016-07-04
Status
Completed
Phase
Early phase I
Treatment
KHK4827 140mg SC
Experimental1:KHK4827 140mg subcutaneous injection
Arms:
KHK4827 140mg SC
KHK4827 210mg SC
Experimental2:KHK4827 210mg subcutaneous injection
Arms:
KHK4827 210mg SC
Size
155
Primary endpoint
Incidence and types of adverse events and adverse reactions
28 weeks
Anti-KHK4827 antibody
28 weeks
Eligibility criteria
Inclusion Criteria:
* 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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 155, 'type': 'ACTUAL'}}
Updated at
2023-08-25
1 organization
1 product
5 indications
Organization
Kyowa KirinProduct
KHK4827Indication
Psoriasis VulgarisIndication
Psoriatic ArthritisIndication
PsoriasisIndication
Palmaris Et PlantarisIndication
Erythrodermic psoriasis