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Clinical Trials in the USA / NCT07120503
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 USA tracker
Sponsor
Windward Bio
Phase
Phase 2
Started
2025-07-24
Last updated
2026-10-21

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

WIN378 →Placebo

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

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

Study summary

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.

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: 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

Primary outcome measure(s)

  • PART A: Number of participants with treatment-emergent adverse events (TEAEs) during the study — Week 0 - Week 60
  • PART A: Number of participants with treatment-emergent serious adverse events (TESAEs) during the study — Week 0 - Week 60
  • PART A: Number of participants with abnormal vital signs during the study — Week 0 - Week 60
  • PART A: Number of participants with abnormal laboratory assessments during the study — Week 0 - Week 60
  • PART A: Number of participants with Clinically significant abnormal ECG results during the study — Week 0 - Week 60
  • PART A: WIN 378 Pharmacokinetics: concentration at trough [Ctrough] — Week 0 - Week 60
  • PART A: WIN 378 Pharmacokinetics: area under the concentration time curve [AUC] — Week 0 - Week 60
  • PART A: WIN 378 Pharmacokinetics: maximum observed concentration [Cmax]) — Week 0 - Week 60
  • PART A: Number of participants with positive anti-drug antibodies (ADA) during the study — Week 0 - Week 60
  • PART B: Annualized Asthma Exacerbation Rate (AAER) — 24 Weeks after last dose

Trial sites (73)

FacilityCityRegionStatus
WB Contracted Clinical Research Site Los Angeles California Active Not Recruiting
WB Contracted Clinical Research Site San Jose California Active Not Recruiting
WB Contracted Clinical Research Site Melbourne Florida Recruiting
WB Contracted Clinical Research Site Miami Florida Active Not Recruiting
WB Contracted Clinical Research Site White Marsh Maryland Active Not Recruiting
WB Contracted Clinical Research Site Stow Massachusetts Active Not Recruiting
WB Contracted Clinical Research Site Detroit Michigan Active Not Recruiting
WB Contracted Clinical Research Site Richfield Minnesota Active Not Recruiting
WB Contracted Clinical Research Site St Louis Missouri Active Not Recruiting
WB Contracted Clinical Research Site Bellevue Nebraska Active Not Recruiting
WB Contracted Clinical Research Site Toledo Ohio Recruiting
WB Contracted Clinical Research Site Edmond Oklahoma Active Not Recruiting
WB Contracted Clinical Research Site Pittsburgh Pennsylvania Active Not Recruiting
WB Contracted Clinical Research Site Charleston South Carolina Active Not Recruiting
WB Contracted Clinical Research Site Spartanburg South Carolina Active Not Recruiting
WB Contracted Clinical Research Site Austin Texas Active Not Recruiting
WB Contracted Clinical Research Site El Paso Texas Active Not Recruiting
WB Contracted Clinical Research Site McKinney Texas Recruiting
WB Contracted Clinical Research Site San Antonio Texas Active Not Recruiting
WB Contracted Clinical Research Site Tyler Texas Active Not Recruiting
WB Contracted Clinical Research Site Richmond Virginia Active Not Recruiting
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D. Active Not Recruiting
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D. Active Not Recruiting
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D. Recruiting
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D. Recruiting
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D. Active Not Recruiting
WB Contracted Clinical Research Site Buenos Aires Buenos Aires F.D. Active Not Recruiting
WB Contracted Clinical Research Site Córdoba Córdoba Province Recruiting
WB Contracted Clinical Research Site Paraná Entre Ríos Province Recruiting
WB Contracted Clinical Research Site Rosario Santa Fe Province Active Not Recruiting
WB Contracted Clinical Research Site Rosario Santa Fe Province Active Not Recruiting
WB Contracted Clinical Research Site Santa Fe Santa Fe Province Recruiting
WB Contracted Clinical Research Site San Miguel de Tucumán Tucumán Province Active Not Recruiting
WB Contracted Clinical Research Site San Miguel de Tucumán Tucumán Province Active Not Recruiting
WB Contracted Clinical Research Site San Miguel de Tucumán Tucumán Province Recruiting
WB Contracted Clinical Research Site Brookvale New South Wales Active Not Recruiting
WB Contracted Clinical Research Site Coffs Harbour New South Wales Active Not Recruiting
WB Contracted Clinical Research Site Maroubra New South Wales Active Not Recruiting
WB Contracted Clinical Research Site Miranda New South Wales Active Not Recruiting
WB Contracted Clinical Research Site Wollongong New South Wales Active Not Recruiting

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

More Windward Bio trials in the USA

A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius) Recruiting

Other trials for the same condition

A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma Recruiting
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma Active, not recruiting
A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD Active, not recruiting
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma Recruiting
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma Enrolling by invitation
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 the USA