[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635063":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":25,"responsibleParty":44,"collaborators":25,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":25,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":25,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":25},{"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",{"type":45,"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":57,"type":58},50,"ESTIMATED","INTERVENTIONAL",[61],"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.",[64],"Hidradenitis Suppurativa",[66,67,68],"Hidradenitis","Skin Diseases","Infections","NOT_YET_RECRUITING","2026-04-17",{"date":72,"type":73},"2026-04-23","ACTUAL",{"date":75,"type":58},"2026-04",{"date":77,"type":58},"2027-04",{"name":5,"class":6}]