Systemic Sclerosis
Conditions
Keywords
systemic sclerosis, brodalumab, KHK4827
Brief summary
Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis
Interventions
DRUGKHK4827
210 mg every 2 weeks (Q2W), subcutaneous (SC) injection
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
1. 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 2. 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 3. 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 4. Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum KHK4827 concentration | Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2025. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in modified Rodnan skin score (mRSS) from baseline | Pre-dose, Week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and every 8 weeks through study completion until 2025. | mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51 |
Countries
Japan
Outcome results
None listed