A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

Other illness

• 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

Lab values

• 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

Other

• 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

• 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