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Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Sponsor: Windward Bio
Summary
This is a global Phase 2 study divided in two parts. Part A is a double-blind, randomized dose-range finding study in adults with moderate to severe asthma to confirm the dosing regimen of WIN378 that can be tested in future pivotal trials for efficacy and safety. Part B is a pivotal double-blind, randomized study to demonstrate the efficacy and safety of WIN378 in adults with severe uncontrolled asthma. Two dose levels of WIN378 will be tested against placebo to evaluate AAER, lung function, asthma control, asthma-related quality of life and other important efficacy endpoints.
Official title: A Phase 2 Randomized, Double-blind Placebo-Controlled Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety and Efficacy of WIN378 in Adult Participants With Moderate or Severe Asthma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-07-24
Completion Date
2028-11-23
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
WIN378
WIN378 is a fully human, ultra-long-acting monoclonal antibody given twice-yearly that binds to thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving asthma control over the extended dosing interval.
Placebo
A sham injection consisting of placebo to mask WIN378.
Locations (73)
WB Contracted Clinical Research Site
Los Angeles, California, United States
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San Jose, California, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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White Marsh, Maryland, United States
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Stow, Massachusetts, United States
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Detroit, Michigan, United States
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Richfield, Minnesota, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Toledo, Ohio, United States
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Edmond, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Spartanburg, South Carolina, United States
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Austin, Texas, United States
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El Paso, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Richmond, Virginia, United States
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Buenos Aires, Buenos Aires F.D., Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Córdoba, Córdoba Province, Argentina
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Paraná, Entre Ríos Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Brookvale, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Maroubra, New South Wales, Australia
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Miranda, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Birtinya, Queensland, Australia
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North Altona, Victoria, Australia
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Sofia, Grad Sofia, Bulgaria
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Lovech, Lovech, Bulgaria
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Rousse, Ruse, Bulgaria
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Sofia, Sofia, Bulgaria
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Sofia, Sofia, Bulgaria
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Pessac, Bordeaux, France
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Dijon, Côte-dOr, France
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Montpellier, Hérault, France
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La Tronche, Isère, France
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Nantes, Loire-Atlantique, France
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Berlin, Loire-Atlantique, Germany
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München, Loire-Atlantique, Germany
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Bendorf, Rhineland-Palatinate, Germany
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Lübeck, Schleswig-Holstein, Germany
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Darmstadt, Germany
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Frankfurt am Main, Germany
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Frankfurt am Main, Germany
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Leipzig, Germany
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Mainz, Germany
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München, Germany
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Chiclana de la Frontera, Cádiz, Spain
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Madrid, Entre Ríos, Spain
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San Sebastián, Guipúzcoa, Spain
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Madrid, Madrid, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Benalmádena, Málaga, Spain
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Málaga, Málaga, Spain
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Seville, Sevilla, Spain
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Linköping, Ostergotlands, Sweden
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Malmö, Skåne County, Sweden
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Stockholm, Stockholm County, Sweden