Status:
COMPLETED
A Study of KHK4827 in Patients With Systemic Sclerosis
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis
Eligibility Criteria
Inclusion
- Subject meets the criteria for diagnosis of the Diagnostic Criteria, Severity Classification, and Clinical Practice Guidelines for Systemic Sclerosis （Japanese Dermatological Association 2016） at the pre-examination
- Subject presented the first symptoms of sclerosis other than Raynaud's phenomenon within 60 months before enrollment
- Subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mRSS of 10 to \<30 at the pre-examination and who has progressing skin thickening
Exclusion
- Any of the following significant concomitant diseases:
- Type 1 diabetes
- Poorly controlled type 2 diabetes (HbA1c \> 8.5%)
- Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification)
- Myocardial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product
- Poorly controlled hypertension (systolic pressure \> 150 mm Hg or diastolic pressure \> 90 mg Hg at screening)
- Severe chronic lung disease (%Forced Vital Capacity (FVC) \< 60% and %Diffusing capacity of lung for carbon monoxide (DLco) \< 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calculated with the LMS Method and Compared with Previous Values \[Japanese Respiratory Society\])
- Major chronic inflammatory diseases or connective tissue diseases other than scleroderma
- Patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
- Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04368403
Start Date
October 6 2017
End Date
March 31 2025
Last Update
July 11 2025
Active Locations (1)
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1
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan, 113-8655