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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Page 1 of 19 (73 locations)

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

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