[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635063":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Almirall, S.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LAD328","EXPERIMENTAL","Participants will receive LAD328 Dose A, intravenous (IV) infusion.",[13],"Drug: LAD328",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo diluent solution for IV infusion.",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","LAD328 administered intravenously.",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","Placebo administered intravenously.",[15],[31],{"name":32,"affiliation":5,"role":33},"Study Director","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Estrella Garcia","CONTACT","+34620985953","gco@almirall.com",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Andrea Pejenaute","+34 697189586","apejenaute@almirall.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Alm Site 1","RECRUITING","Warsaw","Masovian Voivodeship","02-953","Poland","PL",{"type":54,"coordinates":55},"Point",[56,57],21.01178,52.22977,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":25,"email":63},"Justyna Skibinska","0048726101000","recepcja@klinikaambroziak.pl",{"type":65,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100635063","phase-2-a-proof-of-concept-study-of-lad328-in-adults-with-hidradenitis-suppurativa-100635063",false,"NCT07547813","A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa","A Phase 2, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate Efficacy and Safety of LAD328 in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa","Inclusion Criteria:\n\n* Male or female between 18 and 65 years old inclusive.\n* A diagnosis of moderate-to-severe HS defined as a total of \\>=5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits, with a clinical history of HS for at least 6 months.\n* HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits.\n* History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit.\n* Agree to regularly use, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study.\n* Participants who are woman of child-bearing potential (WOCBP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD328 during the trial.\n\nExclusion Criteria:\n\n* HS with \\>20 draining tunnels either at the Screening or Baseline visits.\n* Ongoing medical conditions (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive\u002Fimmunomodulating treatments (e.g., methotrexate, ciclosporin, corticosteroids, cytokine-targeted therapy and JAK inhibitors) during the trial.\n* Known or suspected hypersensitivity to trial product or any of its excipients.\n* Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.\n* Prior treatment with LAD328.\n* Live and attenuated vaccinations 4 weeks prior Pre-treatment or is planning to receive any such vaccine during the trial.\n* Females who are pregnant or breast-feeding or seeking to become pregnant during the trial.","ALL","18 Years","65 Years",{"count":77,"type":78},50,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","The main purpose of this study is to evaluate the effect of LAD328 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS), and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.",[84],"Hidradenitis Suppurativa",[86,87,88],"Hidradenitis","Skin Diseases","Infections","2026-08-14",{"date":91,"type":92},"2026-08-17","ACTUAL",{"date":94,"type":92},"2026-05-13",{"date":96,"type":78},"2027-04",{"name":5,"class":6},1]