[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627972":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":65,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":19,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":19,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Seismic Therapeutic AU Pty Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"S-4321","EXPERIMENTAL","SC Dose of S-4321",[13],"Drug: S-4321",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Multiple doses of S-4321 via subcutaneous administration",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Jennifer Martin, MD","Novatrials","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Seismic Contact","CONTACT","1800 244 475","clinical@seismictx.com",[32,50],{"facility":23,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Charlestown","New South Wales","2290","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],151.69318,-32.96828,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":19,"email":49},"Toni McCallum Pardey","+61 (02) 4089 3746","toni@novatrials.com.au",{"facility":51,"status":33,"city":52,"state":53,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"University of the Sunshine Coast Clinical Trials, Birtinya","Birtinya","Queensland","4575",{"type":40,"coordinates":56},[57,58],153.11913,-26.74322,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":63,"phoneExt":19,"email":64},"Peter de Wet, MD","+61 (07) 5456 3872","ctcvitality@usc.edu.au",{"type":66,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[68],{"name":69,"class":6},"Avance Clinical Pty Ltd.","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":81,"type":82},24,"ESTIMATED","INTERVENTIONAL",[85],"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).",[88,89,90,91,92,93],"Autoimmune Diseases","Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Psoriasis (PsO)","Cutaneous Lupus Erythematosus (CLE)","Atopic Dermatitis (AD)",[95,96,9,97,98,93,91,90,92,99],"Autoimmune","Immune-mediated","Seismic Therapeutic","Rheumatoid Arthritis","Cutaneous Lupus","2026-05-28",{"date":102,"type":103},"2026-06-01","ACTUAL",{"date":105,"type":82},"2026-06",{"date":107,"type":82},"2027-09",{"name":5,"class":6},2]