Moderate to Severe Systemic Sclerosis
Conditions
Keywords
systemic sclerosis, brodalumab, KHK4827
Brief summary
To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening
Interventions
DRUGKHK4827
210 mg Q2W, SC
DRUGPlacebo
Q2W, SC
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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) * Myocartial 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 (%FVC \< 60% and %DLco \< 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calcluated 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 | Description |
|---|---|---|
| Change in modified Rodnan skin score (mRSS) from baseline at Week 24 | at least 2 weeks up to 24 weeks | mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51 |
Secondary
| Measure | Time frame |
|---|---|
| Change in modified Rodnan skin score (mRSS) from baseline at Week 52 | at least 2 weeks up to 52 weeks |
Countries
Japan
Outcome results
None listed