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

NCT07455578 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-06

No results posted yet for this study

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 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).

Conditions

  • Autoimmune Diseases
  • Rheumatoid Arthritis (RA)
  • Psoriatic Arthritis (PsA)
  • Psoriasis (PsO)
  • Cutaneous Lupus Erythematosus (CLE)
  • Atopic Dermatitis (AD)

Interventions

DRUG

S-4321

S-4321 via subcutaneous administration

Sponsors & Collaborators

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • Seismic Therapeutic AU Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Jennifer Martin, MD · Novatrials

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-06-30
Completion
2027-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07455578 on ClinicalTrials.gov