[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Seismic Therapeutic AU Pty Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100627972","phase-1-study-of-s-4321-in-participants-with-an-autoimmune-or-immune-mediated-disease-100627972",false,"NCT07455578","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","All Participants Major Inclusion Criteria:\n\n1. Adult males and females, 18 to 75 years of age (inclusive)\n2. Body mass index (BMI) ≥18.0 and \\\u003C40.0 kg\u002Fm2 with a minimum body weight of 45 kg\n3. 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.\n\nAll Participants Major Exclusion Criteria:\n\n1. 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.\n2. Have received azathioprine, cyclosporine, mycophenolate mofetil, or tacrolimus within 4 weeks\n3. Unable or unwilling to discontinue a prohibited medication\n4. Presence of clinically relevant immunosuppression\n5. Current infection or history of severe infection\n6. Any history of malignant disease, with some exceptions\n\nMajor inclusion\u002Fexclusion for each autoimmune or immune-mediated disease:\n\nFor RA:\n\n1. Confirmed diagnosis of moderate to severe active RA by the American College of Rheumatology (ACR) 2010\u002FEuropean League Against Rheumatism (EULAR) criteria for at least 3 months prior to the Screening 1 visit, and:\n\n   1. ≥6 swollen joint count based on 66 joint count\n   2. ≥6 tender joint count based on 68 joint count\n   3. Seropositive for RF and\u002For ACPA\n   4. Elevated hsCRP ≥1.2 times greater than the ULN\n   5. Does not have Class IV RA according to ACR revised criteria\n2. Inadequate response to, or loss of response, or intolerance to:\n\n   1. \\>1 conventional synthetic DMARD after 3 months of therapy OR\n   2. \\>1 biologic DMARD\u002Ftargeted synthetic DMARD after 3 months of therapy\n   3. Has not failed 3 or more bDMARDs and\u002For tsDMARDs\n\nFor PsA:\n\n1. 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:\n\n   1. Active PsO defined by at least 1 psoriasis lesion\n   2. Active disease defined by \\>3 swollen joints and \\>3 tender joints using the 76\u002F78 swollen and tender joint count\n2. 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\n3. Participants may be TNF inhibitor therapy naïve or may have received 1 prior TNF inhibitor\n4. Has not had inadequate response or intolerance to 2 or more bDMARDs or csDMARDs\n\nFor PsO:\n\n1. Confirmed diagnosis of moderate to severe plaque PsO for at least 6 months, with all of the following:\n\n   1. Psoriasis Area and Severity Index (PASI) \\>12 points\n   2. Static Physician's Global Assessment (sPGA) \\>3 points\n   3. Body surface area (BSA) of PsO involvement \\>10%\n2. Cannot have a clinically significant flare within 12 weeks\n3. Does not have history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis\n4. Has not had inadequate response to more than 2 prior bDMARDs\n\nFor CLE (with or without systemic manifestations):\n\n1. Histologically confirmed diagnosis of CLE with or without systemic manifestations for at least 6 months\n2. Has active skin manifestations as measured by CLASI-A \\>10 or CLASI-A \\>8, if there is no alopecia or mucous membrane lesions\n3. Participant must have an active CLE lesion despite an adequate trial of antimalarial treatment for at least 6 months.\n4. Cannot have active lupus nephritis or moderate-to-severe or chronic kidney disease with eGFR \\\u003C45 mL\u002Fmin\u002F1.73m2\n5. Cannot have active neuropsychiatric SLE\n\nFor AD:\n\n1. 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\n\n   1. Eczema Area and Severity Index (EASI) \\>16\n   2. Validated Investigator Global Assessment (vIGA-AD) \\>3\n   3. BSA of AD involvement \\>10%\n   4. PP-NRS) \\>4 (average of daily scores) during the 7 days prior to dosing\n2. 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:\n\n   1. Inability to achieve good disease control after use TCS for at least 4 weeks\n   2. Documented history of clinically significant AEs with the use of TCS\n   3. Failed systemic therapies intended to treat AD within 6 months\n\nAdditional inclusion\u002Fexclusion criteria will apply.","ALL","18 Years","75 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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).",[27,28,29,30,31,32],"Autoimmune Diseases","Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Psoriasis (PsO)","Cutaneous Lupus Erythematosus (CLE)","Atopic Dermatitis (AD)",[34,35,36,37,38,32,30,29,31,39],"Autoimmune","Immune-mediated","S-4321","Seismic Therapeutic","Rheumatoid Arthritis","Cutaneous Lupus","RECRUITING","2026-05-28",{"date":43,"type":44},"2026-06-01","ACTUAL",{"date":46,"type":21},"2026-06",{"date":48,"type":21},"2027-09",{"name":50,"class":51},"Seismic Therapeutic AU Pty Ltd","INDUSTRY",2,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100583537","phase-1-a-phase-1-study-of-s-4321-100583537","NCT06877611","A Phase 1 Study of S-4321","A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers","Inclusion Criteria:\n\n1. Is available for the entire duration of the study and follow up.\n2. Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n3. Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).\n4. Has a body mass index (BMI) within 18 to 32 kg\u002Fm2, inclusive, and weighs ≥45 kg.\n5. Is in good physical and mental health in the opinion of the Investigator or delegate.\n\nMajor Exclusion Criteria:\n\n1. Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.\n2. Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.\n3. Has a known immunodeficiency disorder.\n4. Has a history of malignancy or confirmed cervical dysplasia.\n5. Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.\n6. Has positive laboratory evidence for active hepatitis at screening.\n7. Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.\n\nOther inclusion\u002Fexclusion eligibility criteria apply.",true,"65 Years",{"count":63,"type":21},96,[24],"This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.",[67],"Healthy Volunteer","2025-04-10",{"date":70,"type":44},"2025-04-15",{"date":72,"type":44},"2025-04-03",{"date":74,"type":21},"2026-04",{"name":50,"class":51},1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":60,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":76},"100579753","phase-1-a-phase-1-study-of-s-1117-100579753","NCT06828393","A Phase 1 Study of S-1117","A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-1117 in Healthy Volunteers","Major Inclusion Criteria:\n\n1. Is available for the entire duration of the study and follow up.\n2. Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n3. Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).\n4. Has a body mass index (BMI) within 18 to 32 kg\u002Fm2, inclusive, and weighs ≥45 kg.\n5. Is in good physical and mental health in the opinion of the Investigator or delegate.\n\nMajor Exclusion Criteria:\n\n1. Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.\n2. Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.\n3. Has a known immunodeficiency disorder.\n4. Has a history of malignancy other than non-melanoma skin cancer.\n5. Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.\n6. Has positive laboratory evidence for active hepatitis at screening.\n7. Has received a live vaccine within 2 months of Screening.\n8. Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.\n\nOther inclusion\u002Fexclusion eligibility criteria apply.",{"count":63,"type":21},[24],"This is the first-in-human study of S-1117 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.",[67],"2025-03-09",{"date":90,"type":44},"2025-03-12",{"date":92,"type":21},"2025-03",{"date":94,"type":21},"2026-03",{"name":50,"class":51},""]