RecruitingPhase 2NCT07120503

Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

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


Sponsor

Windward Bio

Enrollment

136 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate or severe asthma. WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms. The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called WIN378 in adults with moderate or severe asthma that is not well controlled despite using inhaled corticosteroids (ICS) and at least one other controller medication (like a long-acting beta-agonist). The goal is to evaluate the drug's safety, how it behaves in the body, and whether it helps control asthma. **You may be eligible if...** - You have a physician diagnosis of asthma with confirmed airway reversibility in the past 2 years - Your lung function (FEV1) is between 30–90% of predicted - You are currently using low, medium, or high-dose inhaled corticosteroids plus at least one additional controller medication - You are not pregnant and are using reliable contraception (if able to become pregnant) **You may NOT be eligible if...** - You have another significant lung disease other than asthma - You have active or recent tuberculosis (within 12 months) - You are a heavy smoker (10 or more pack-years) - You have a history of cancer - You recently received a biologic drug for asthma or are on immunosuppressants - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWIN378

WIN378 is a fully human, long-acting monoclonal antibody that binds to thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving asthma control over an extended dosing interval.

DRUGPlacebo

A sham injection consisting of placebo to mask WIN378.


Locations(64)

WB Contracted Clinical Research Site

Los Angeles, California, United States

WB Contracted Clinical Research Site

San Jose, California, United States

WB Contracted Clinical Research Site

Melbourne, Florida, United States

WB Contracted Clinical Research Site

Miami, Florida, United States

WB Contracted Clinical Research Site

White Marsh, Maryland, United States

WB Contracted Clinical Research Site

Richfield, Minnesota, United States

WB Contracted Clinical Research Site

St Louis, Missouri, United States

WB Contracted Clinical Research Site

Bellevue, Nebraska, United States

WB Contracted Clinical Research Site

Toledo, Ohio, United States

WB Contracted Clinical Research Site

Edmond, Oklahoma, United States

WB Contracted Clinical Research Site

Charleston, South Carolina, United States

WB Contracted Clinical Research Site

Spartanburg, South Carolina, United States

WB Contracted Clinical Research Site

Austin, Texas, United States

WB Contracted Clinical Research Site

El Paso, Texas, United States

WB Contracted Clinical Research Site

McKinney, Texas, United States

WB Contracted Clinical Research Site

San Antonio, Texas, United States

WB Contracted Clinical Research Site

Tyler, Texas, United States

WB Contracted Clinical Research Site

Richmond, Virginia, United States

WB Contracted Clinical Research Site

Buenos Aires, Buenos Aires F.D., Argentina

WB Contracted Clinical Research Site

Buenos Aires, Buenos Aires F.D., Argentina

WB Contracted Clinical Research Site

Buenos Aires, Buenos Aires F.D., Argentina

WB Contracted Clinical Research Site

Buenos Aires, Buenos Aires F.D., Argentina

WB Contracted Clinical Research Site

Buenos Aires, Buenos Aires F.D., Argentina

WB Contracted Clinical Research Site

Buenos Aires, Buenos Aires F.D., Argentina

WB Contracted Clinical Research Site

Córdoba, Córdoba Province, Argentina

WB Contracted Clinical Research Site

Santa Fe, Santa Fe Province, Argentina

WB Contracted Clinical Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

WB Contracted Clinical Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

WB Contracted Clinical Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

WB Contracted Clinical Research Site

Brookvale, New South Wales, Australia

WB Contracted Clinical Research Site

Coffs Harbour, New South Wales, Australia

WB Contracted Clinical Research Site

Maroubra, New South Wales, Australia

WB Contracted Clinical Research Site

Miranda, New South Wales, Australia

WB Contracted Clinical Research Site

Wollongong, New South Wales, Australia

WB Contracted Clinical Research Site

North Altona, Victoria, Australia

WB Contracted Clinical Research Site

Sofia, Grad Sofia, Bulgaria

WB Contracted Clinical Research Site

Lovech, Lovech, Bulgaria

WB Contracted Clinical Research Site

Rousse, Ruse, Bulgaria

WB Contracted Clinical Research Site

Sofia, Sofia, Bulgaria

WB Contracted Clinical Research Site

Sofia, Sofia, Bulgaria

WB Contracted Clinical Research Site

Pessac, Bordeaux, France

WB Contracted Clinical Research Site

Dijon, Côte-dOr, France

WB Contracted Clinical Research Site

Montpellier, Hérault, France

WB Contracted Clinical Research Site

La Tronche, Isère, France

WB Contracted Clinical Research Site

Nantes, Loire-Atlantique, France

WB Contracted Clinical Research Site

Berlin, Loire-Atlantique, Germany

WB Contracted Clinical Research Site

München, Loire-Atlantique, Germany

WB Contracted Clinical Research Site

Bendorf, Rhineland-Palatinate, Germany

WB Contracted Clinical Research Site

Darmstadt, Germany

WB Contracted Clinical Research Site

Frankfurt am Main, Germany

WB Contracted Clinical Research Site

Frankfurt am Main, Germany

WB Contracted Clinical Research Site

Leipzig, Germany

WB Contracted Clinical Research Site

Mainz, Germany

WB Contracted Clinical Research Site

München, Germany

WB Contracted Clinical Research Site

Chiclana de la Frontera, Cádiz, Spain

WB Contracted Clinical Research Site

San Sebastián, Guipúzcoa, Spain

WB Contracted Clinical Research Site

Madrid, Madrid, Spain

WB Contracted Clinical Research Site

Pozuelo de Alarcón, Madrid, Spain

WB Contracted Clinical Research Site

Benalmádena, Málaga, Spain

WB Contracted Clinical Research Site

Málaga, Málaga, Spain

WB Contracted Clinical Research Site

Seville, Sevilla, Spain

WB Contracted Clinical Research Site

Linköping, Ostergotlands, Sweden

WB Contracted Clinical Research Site

Malmo, Skåne County, Sweden

WB Contracted Clinical Research Site

Stockholm, Stockholm County, Sweden

View Full Details on ClinicalTrials.gov

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NCT07120503


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