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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Phase 1b, Open-Label, Exploratory Biomarker Basket Study of S-4321 in Participants With an Autoimmune or Immune-Mediated Disease

Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease (NCT07455578) is a Phase 1 interventional studying Autoimmune Diseases and Rheumatoid Arthritis (RA), sponsored by Seismic Therapeutic AU Pty Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Autoimmune Diseases, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

All Participants Major Who May Qualify: 1. Adult males and females, 18 to 75 years of age (inclusive) 2. Body mass index (BMI) ≥18.0 and \<40.0 kg/m2 with a minimum body weight of 45 kg 3. Use of adequate contraception for both males and females. Female volunteers must be of nonchildbearing potential or if of childbearing potential, must have a negative pregnancy test. All Participants Major Who Should NOT Join This Trial: 1. Have received a PD-1 agonist, immune checkpoint agonist, immune checkpoint inhibitor, anti-CD19 or anti-CD20 agents, cell therapy, B cell modulating agents, alkylating agents, or any other immune cell depleting therapy. 2. Have received azathioprine, cyclosporine, mycophenolate mofetil, or tacrolimus within 4 weeks 3. Unable or unwilling to discontinue a prohibited medication 4. Presence of clinically relevant immunosuppression 5. Current infection or history of severe infection 6. Any history of malignant disease, with some exceptions Major inclusion/exclusion for each autoimmune or immune-mediated disease: For RA: 1. Confirmed diagnosis of moderate to severe active RA by the American College of Rheumatology (ACR) 2010/European League Against Rheumatism (EULAR) criteria for at least 3 months prior to the Screening 1 visit, and: 1. ≥6 swollen joint count based on 66 joint count 2. ≥6 tender joint count based on 68 joint count 3. Seropositive for RF and/or ACPA 4. Elevated hsCRP ≥1.2 times greater than the ULN 5. Does not have Class IV RA according to ACR revised criteria 2. Inadequate response to, or loss of response, or intolerance to: 1. \>1 conventional synthetic DMARD after 3 months of therapy OR 2. \>1 biologic DMARD/targeted synthetic DMARD after 3 months of therapy 3. Has not failed 3 or more bDMARDs and/or tsDMARDs For PsA: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
All Participants Major Inclusion Criteria: 1. Adult males and females, 18 to 75 years of age (inclusive) 2. Body mass index (BMI) ≥18.0 and \<40.0 kg/m2 with a minimum body weight of 45 kg 3. Use of adequate contraception for both males and females. Female volunteers must be of nonchildbearing potential or if of childbearing potential, must have a negative pregnancy test. All Participants Major Exclusion Criteria: 1. Have received a PD-1 agonist, immune checkpoint agonist, immune checkpoint inhibitor, anti-CD19 or anti-CD20 agents, cell therapy, B cell modulating agents, alkylating agents, or any other immune cell depleting therapy. 2. Have received azathioprine, cyclosporine, mycophenolate mofetil, or tacrolimus within 4 weeks 3. Unable or unwilling to discontinue a prohibited medication 4. Presence of clinically relevant immunosuppression 5. Current infection or history of severe infection 6. Any history of malignant disease, with some exceptions Major inclusion/exclusion for each autoimmune or immune-mediated disease: For RA: 1. Confirmed diagnosis of moderate to severe active RA by the American College of Rheumatology (ACR) 2010/European League Against Rheumatism (EULAR) criteria for at least 3 months prior to the Screening 1 visit, and: 1. ≥6 swollen joint count based on 66 joint count 2. ≥6 tender joint count based on 68 joint count 3. Seropositive for RF and/or ACPA 4. Elevated hsCRP ≥1.2 times greater than the ULN 5. Does not have Class IV RA according to ACR revised criteria 2. Inadequate response to, or loss of response, or intolerance to: 1. \>1 conventional synthetic DMARD after 3 months of therapy OR 2. \>1 biologic DMARD/targeted synthetic DMARD after 3 months of therapy 3. Has not failed 3 or more bDMARDs and/or tsDMARDs For PsA: 1. Confirmed diagnosis of adult-onset PsA classified by the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 3 months prior to the Screening 1 visit, with all of the following: 1. Active PsO defined by at least 1 psoriasis lesion 2. Active disease defined by \>3 swollen joints and \>3 tender joints using the 76/78 swollen and tender joint count 2. Received standard doses of NSAIDs for \>4 weeks or csDMARDs for \>3 months and has been on a stable dose for \>8 weeks, or participant has intolerance to NSAIDs or DMARDs 3. Participants may be TNF inhibitor therapy naïve or may have received 1 prior TNF inhibitor 4. Has not had inadequate response or intolerance to 2 or more bDMARDs or csDMARDs For PsO: 1. Confirmed diagnosis of moderate to severe plaque PsO for at least 6 months, with all of the following: 1. Psoriasis Area and Severity Index (PASI) \>12 points 2. Static Physician's Global Assessment (sPGA) \>3 points 3. Body surface area (BSA) of PsO involvement \>10% 2. Cannot have a clinically significant flare within 12 weeks 3. Does not have history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis 4. Has not had inadequate response to more than 2 prior bDMARDs For CLE (with or without systemic manifestations): 1. Histologically confirmed diagnosis of CLE with or without systemic manifestations for at least 6 months 2. Has active skin manifestations as measured by CLASI-A \>10 or CLASI-A \>8, if there is no alopecia or mucous membrane lesions 3. Participant must have an active CLE lesion despite an adequate trial of antimalarial treatment for at least 6 months. 4. Cannot have active lupus nephritis or moderate-to-severe or chronic kidney disease with eGFR \<45 mL/min/1.73m2 5. Cannot have active neuropsychiatric SLE For AD: 1. Confirmed diagnosis of AD as defined by the American Academy of Dermatology: Guidelines of Care for the Management of Atopic Dermatitis for at least 12 months 1. Eczema Area and Severity Index (EASI) \>16 2. Validated Investigator Global Assessment (vIGA-AD) \>3 3. BSA of AD involvement \>10% 4. PP-NRS) \>4 (average of daily scores) during the 7 days prior to dosing 2. Inadequate response to existing topical medications within 6 months or has a history of intolerance to topical therapy as defined by at least 1 of the following: 1. Inability to achieve good disease control after use TCS for at least 4 weeks 2. Documented history of clinically significant AEs with the use of TCS 3. Failed systemic therapies intended to treat AD within 6 months Additional inclusion/exclusion criteria will apply.

Treatments Being Tested

DRUG

S-4321

Multiple doses of S-4321 via subcutaneous administration

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Novatrials
Charlestown, New South Wales, Australia
University of the Sunshine Coast Clinical Trials, Birtinya
Birtinya, Queensland, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07455578), the sponsor (Seismic Therapeutic AU Pty Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07455578 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07455578?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07455578?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07455578. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07455578. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.