RecruitingAsthma

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

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.

Sponsor: Windward Bio

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: PART A of ≥ 30% and ≤ 90%, predicted; PART B of ≥ 30% and ≤ 80%, predicted
✓ PART A Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)
✓ PART B: medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)
✓ Part B: History of at least of 2 asthma exacerbations within 12 months before V1

You may not qualify if…

✕ Participants with a known, pre-existing, clinically important lung condition other than asthma
✕ 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