Clinical Trial

Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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).
Protocol Amendment History 3 changes
critical Recruitment opened 2026-06-02
notable Primary completion pushed: 2027-06 -> 2027-09 2026-06-02
minor Completion pushed: 2027-06 -> 2027-09 2026-06-02
Trial Details
NCT Number NCT07455578
Lead Sponsor Seismic Therapeutic AU Pty Ltd
Collaborators: Avance Clinical Pty Ltd.
Conditions Autoimmune Diseases, Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Psoriasis (PsO), Cutaneous Lupus Erythematosus (CLE), Atopic Dermatitis (AD)
Enrollment 24 participants
Start Date 2026-06
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-01