[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641876":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":84,"collaborators":28,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":28,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":45,"whyStopped":28,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Windward Bio","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"WIN378 Dose 1","EXPERIMENTAL","WIN378 SC injections will be administered",[13],"Drug: WIN378",{"label":15,"type":10,"description":11,"interventionNames":16},"WIN378 Dose 2",[13],{"label":18,"type":10,"description":19,"interventionNames":20},"Placebo","Placebo SC injections will be administered",[21],"Drug: Placebo",[23,29],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","WIN378","WIN378 is a fully human, long-acting monoclonal antibody that targets the ligand of thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving COPD control over an extended dosing interval",[9,15],null,{"type":24,"name":18,"description":30,"armGroupLabels":31,"otherNames":28},"Placebo matching WIN378",[18],[33],{"name":34,"affiliation":5,"role":35},"Omar Khwaja, MD","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":28,"email":41},"Juliana Hutchinson, MSc","CONTACT","+4161 551 75 75","clinical.trial.enquiry@windwardbio.com",[43,57,66,75],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":28},"WB Contracted Clinical Research Site","RECRUITING","Miami Lakes","Florida","33014","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-80.30866,25.90871,{"lat":55,"lon":54},{"facility":44,"status":45,"city":58,"state":59,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":65,"contacts":28},"North Dartmouth","Massachusetts","02747",{"type":52,"coordinates":62},[63,64],-70.97032,41.63899,{"lat":64,"lon":63},{"facility":44,"status":45,"city":67,"state":68,"zip":69,"country":49,"countryCode":50,"cosmosGeoPoint":70,"geoPoint":74,"contacts":28},"Charlotte","North Carolina","28277",{"type":52,"coordinates":71},[72,73],-80.84313,35.22709,{"lat":73,"lon":72},{"facility":44,"status":45,"city":76,"state":77,"zip":78,"country":49,"countryCode":50,"cosmosGeoPoint":79,"geoPoint":83,"contacts":28},"McKinney","Texas","75069",{"type":52,"coordinates":80},[81,82],-96.61527,33.19762,{"lat":82,"lon":81},{"type":85,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100641876","phase-2-a-study-of-win378-in-participants-with-moderate-to-severe-copd-sirius-100641876",false,"NCT07646587","A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)","A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of WIN378 in Participants With Moderate - Severe Chronic Obstructive Pulmonary Disease","Sirius","Inclusion Criteria:\n\n* Adults aged 40 to 80 years\n* Post-BD spirometry at screening FEV1\u002FFVC \\\u003C 0.70 and FEV1 30-80% predicted\n* On stable triple inhaled therapy (ICS\u002FLABA\u002FLAMA) for ≥ 3 months\n* Former smoker (≥ 10 pack-year history) and abstinence from smoking for ≥ 6 months\n* Elevated eosinophil count\n* Weight\u002FBMI within allowed range\n\nExclusion Criteria:\n\n* Clinically significant pulmonary disease other than chronic obstructive pulmonary disease (COPD)\n* Clinically significant comorbid medical conditions or infections that, in the investigator's judgment, could affect participant safety or interfere with study conduct\n* Clinically significant cardiovascular disease\n* Recent respiratory infection or COPD exacerbation\n* Exposure to approved or experimental biologic therapies for COPD with less than 5 half-life washout period\n* Pregnancy or breastfeeding\n* Smoking or diagnosed substance use disorder\n* Any condition or circumstance that, in the investigator's opinion, would make participation unsafe or compromise study integrity","ALL","40 Years","80 Years",{"count":98,"type":99},105,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms. The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)",[105],"COPD (Chronic Obstructive Pulmonary Disease)",[107,108,109,110,111,112,113],"COPD","Chronic Obstructive Pulmonary Disease","Respiratory Disease","Monoclonal Antibody","Inflammation","TSLP","Moderate - Severe","2026-06-16",{"date":116,"type":117},"2026-06-22","ACTUAL",{"date":119,"type":117},"2026-06-02",{"date":121,"type":99},"2028-01-07",{"name":5,"class":6},4]