Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Lead Sponsor:
Windward Bio
Conditions:
Asthma (Diagnosis)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 inflam...
Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy and pharmacokinetics of WIN378 in adult participants wit...
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
Key Trial Info
Start Date :
July 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT07120503
Start Date
July 24 2025
End Date
October 1 2027
Last Update
April 7 2026
Active Locations (73)
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1
WB Contracted Clinical Research Site
Los Angeles, California, United States, 90025-7014
2
WB Contracted Clinical Research Site
San Jose, California, United States, 95117
3
WB Contracted Clinical Research Site
Melbourne, Florida, United States, 32763
4
WB Contracted Clinical Research Site
Miami, Florida, United States, 33175