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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Asthma (Diagnosis)

In brief

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).

Key facts

Study ID

NCT07120503

Run by

Windward Bio

People needed

136

Starts

2025-07-24

Expected to finish

2027-10-01

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written Informed Consent Form
• Females that are not pregnant or breastfeeding with following condition: not a woman of childbearing potential or woman of childbearing potential using a highly effective contraception method
• Physician-diagnosis of asthma and documented evidence of airway reversibility during prior 24 months or during screening
• Airflow limitation as indicated by pre-BD FEV1 value of ≥ 30% and ≤ 90%, predicted at two visits at Screening
• Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)

You may not qualify if…

• Participants with a known, pre-existing, clinically important lung condition other than asthma
• Active tuberculosis or treatment required for tuberculosis within 12 months
• Current or former smokers ≥10 pack years
• History of cancer
• Receipt of any marketed biologic agent within 4 months or 5 half-lives prior to screening; receipt of immunoglobulin or blood products within 30 days prior to screening or during the Screening Run-in period; receipt of any live or attenuated vaccines within 15 days prior to screening
• Helminth infection within 24 weeks prior to screening
• Use of immunosuppressive medication within 3 months prior to Screening Visit or during the Screening Run-in period
• Participants who are pregnant, lactating or breastfeeding

Where it is running

• 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 — Stow, Massachusetts, United States
• WB Contracted Clinical Research Site — Detroit, Michigan, 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 — Pittsburgh, Pennsylvania, 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 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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