This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of S-4321 in adults with autoimmune or immune-mediated disease including rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), cutaneous lupus erythematosus (CLE) with or without systemic manifestations, or atopic dermatitis (AD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
S-4321 via subcutaneous administration
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Through Week 16
Incidence of serious adverse events (SAEs)
Time frame: Through Week 16
Serum concentration of S-4321
Time frame: Through Week 16
Change from baseline in percent Receptor Occupancy (RO)
Time frame: Through Week 16
Change from baseline of soluble PD-1 (sPD-1)
Time frame: Through Week 16
Incidence of anti-drug antibodies (ADAs)
Time frame: Through Week 16
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