Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Windward Bio · NCT07120503
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 600
- US sites recruiting
- 3
- Study start
- July 24, 2025
- Record last updated
- October 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: WIN378; Placebo
Conditions: Asthma
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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: 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
Exclusion Criteria
- 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
Recruiting US locations
WB Contracted Clinical Research Site
Melbourne, FL 32763
WB Contracted Clinical Research Site
Toledo, OH 43560
WB Contracted Clinical Research Site
McKinney, TX 75069-8085
Study contacts (from the official record)
- Ayshea Kring · +41 61 551 71 39 · clinical.trial.enquiry@windwardbio.com