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Clinical Trials in Australia / NCT07120503
Active, not recruiting Phase 2

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

NCT07120503 · tracked via the Priya Life Science Australia tracker
Sponsor
Windward Bio
Phase
Phase 2
Started
2025-07-24
Last updated
2026-04-07

Condition(s) studied

Asthma (Diagnosis)

Investigational drug(s) / intervention(s)

WIN378 →Placebo

WIN378: WIN378 is a fully human, long-acting monoclonal antibody that binds to thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving asthma control over an extended dosing interval.

Placebo: A sham injection consisting of placebo to mask WIN378.

Study 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 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with treatment-emergent adverse events (TEAEs) during the study — Week 0 - Week 60
  • Number of participants with treatment-emergent serious adverse events (TESAEs) during the study — Week 0 - Week 60
  • Number of participants with abnormal vital signs during the study — Week 0 - Week 60
  • Number of participants with abnormal laboratory assessments during the study — Week 0 - Week 60
  • Number of participants with Clinically significant abnormal ECG results during the study — Week 0 - Week 60
  • WIN 378 Pharmacokinetics: concentration at trough [Ctrough] — Week 0 - Week 60
  • WIN 378 Pharmacokinetics: area under the concentration time curve [AUC] — Week 0 - Week 60
  • WIN 378 Pharmacokinetics: maximum observed concentration [Cmax]) — Week 0 - Week 60
  • Number of participants with positive anti-drug antibodies (ADA) during the study — Week 0 - Week 60

Trial sites (73)

FacilityCityRegionStatus
WB Contracted Clinical Research Site Los Angeles California
WB Contracted Clinical Research Site San Jose California
WB Contracted Clinical Research Site Melbourne Florida
WB Contracted Clinical Research Site Miami Florida
WB Contracted Clinical Research Site White Marsh Maryland
WB Contracted Clinical Research Site Stow Massachusetts
WB Contracted Clinical Research Site Detroit Michigan
WB Contracted Clinical Research Site Richfield Minnesota
WB Contracted Clinical Research Site St Louis Missouri
WB Contracted Clinical Research Site Bellevue Nebraska
WB Contracted Clinical Research Site Toledo Ohio
WB Contracted Clinical Research Site Edmond Oklahoma
WB Contracted Clinical Research Site Pittsburgh Pennsylvania
WB Contracted Clinical Research Site Charleston South Carolina
WB Contracted Clinical Research Site Spartanburg South Carolina
WB Contracted Clinical Research Site Austin Texas
WB Contracted Clinical Research Site El Paso Texas
WB Contracted Clinical Research Site McKinney Texas
WB Contracted Clinical Research Site San Antonio Texas
WB Contracted Clinical Research Site Tyler Texas
WB Contracted Clinical Research Site Richmond Virginia
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D.
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D.
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D.
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D.
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D.
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D.
WB Contracted Clinical Research Site Córdoba Córdoba Province
WB Contracted Clinical Research Site Paraná Entre Ríos Province
WB Contracted Clinical Research Site Rosario Santa Fe Province
WB Contracted Clinical Research Site Rosario Santa Fe Province
WB Contracted Clinical Research Site Santa Fe Santa Fe Province
WB Contracted Clinical Research Site San Miguel de Tucumán Tucumán Province
WB Contracted Clinical Research Site San Miguel de Tucumán Tucumán Province
WB Contracted Clinical Research Site San Miguel de Tucumán Tucumán Province
WB Contracted Clinical Research Site Brookvale New South Wales
WB Contracted Clinical Research Site Coffs Harbour New South Wales
WB Contracted Clinical Research Site Maroubra New South Wales
WB Contracted Clinical Research Site Miranda New South Wales
WB Contracted Clinical Research Site Wollongong New South Wales

+ 33 more sites — see the full list on the official registry below.

Other trials for the same condition

Multicomponent Breathlessness and Physical Activity Intervention in People With Asthma Using a Digital Platform Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07120503 on ClinicalTrials.gov ↗ ← All trials in Australia