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 multiple doses 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
Multiple doses of S-4321 via subcutaneous administration
Novatrials
Charlestown, New South Wales, Australia
RECRUITINGUniversity of the Sunshine Coast Clinical Trials, Birtinya
Birtinya, Queensland, Australia
RECRUITINGIncidence of treatment-emergent adverse events (TEAEs)
Time frame: Through Week 31
Incidence of serious adverse events (SAEs)
Time frame: Through Week 31
Serum concentration of S-4321
Time frame: Through Week 28
Change from baseline in percent Receptor Occupancy (RO)
Time frame: Through Week 28
Change from baseline of soluble PD-1 (sPD-1)
Time frame: Through Week 28
Incidence of anti-drug antibodies (ADAs)
Time frame: Through Week 28
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