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

NCT07120503

Active Not RecruitingPhase 2

Sponsor: Windward Bio

Conditions: Asthma (Diagnosis)

Interventions: WIN378, Placebo

Countries: United States, Argentina, Australia, Bulgaria, France, Germany, Spain, Sweden

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Locations (73)

Los Angeles, California, United States
San Jose, California, United States
Melbourne, Florida, United States
Miami, Florida, United States
White Marsh, Maryland, United States
Stow, Massachusetts, United States
Detroit, Michigan, United States
Richfield, Minnesota, United States
St Louis, Missouri, United States
Bellevue, Nebraska, United States
Toledo, Ohio, United States
Edmond, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Spartanburg, South Carolina, United States
Austin, Texas, United States
El Paso, Texas, United States
McKinney, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Richmond, Virginia, United States
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Córdoba, Córdoba Province, Argentina
Paraná, Entre Ríos Province, Argentina
Rosario, Santa Fe Province, Argentina
+ 43 more on CT.gov