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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Windward Bio
Sponsor
Windward Bio
Information Provided by (Responsible Party)
Windward Bio
Clinicaltrials.gov Identifier
NCT07120503
Other Study ID Numbers:
WB-2101
First Submitted
July 24, 2025
First Posted
August 12, 2025
Last Update Posted
April 6, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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 with moderate to severe asthma. Participants will continue their standard background asthma therapy according to GINA Steps 3-5. Eligible participants will be randomized to receive WIN378 or placebo administered subcutaneously over a 48-week treatment period, followed by a 12-week safety follow-up.

Condition or DiseaseIntervention/Treatment
Asthma (Diagnosis)
Drug: WIN378Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment136 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 2 Randomized, Double-blind Placebo-Controlled Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety and Efficacy of WIN378 in Adult Participants With Moderate or Severe Asthma
Study Start DateJuly 23, 2025
Actual Primary Completion Date1yr 2mos from now
Actual Study Completion Date1yr 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
WIN378
WIN378 SC injections
Drug: 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
Placebo SC Injections
Drug: Placebo
A sham injection consisting of placebo to mask WIN378.

Outcome Measures

Primary Outcome Measures
  1. Number of participants with treatment-emergent adverse events (TEAEs) during the study
  2. Number of participants with treatment-emergent serious adverse events (TESAEs) during the study
  3. Number of participants with abnormal vital signs during the study
  4. Number of participants with abnormal laboratory assessments during the study
  5. Number of participants with Clinically significant abnormal ECG results during the study
  6. WIN 378 Pharmacokinetics: concentration at trough [Ctrough]
  7. WIN 378 Pharmacokinetics: area under the concentration time curve [AUC]
  8. WIN 378 Pharmacokinetics: maximum observed concentration [Cmax])
  9. Number of participants with positive anti-drug antibodies (ADA) during the study
Secondary Outcome Measures
  1. Change from baseline in FeNO at Week 24 and Week 48
  2. Change from Baseline in Blood eosinophil count at Week 24 and Week 48
  3. Change in pre-BD and post-BD FEV1 at Week 24 and Week 48
  4. Change in pre-BD and post-BD forced vital capacity (FVC) at Week 24 and Week 48
  5. Annualized asthma exacerbation rate (AAER) over 48 weeks
  6. Annualized rate of severe asthma exacerbations over 48 weeks
  7. Time to first asthma exacerbation/severe asthma exacerbation over 48 weeks
  8. Proportion of participants with 1 or more asthma exacerbations/severe asthma exacerbations over 48 weeks
  9. Change from baseline in asthma symptoms (daytime and nighttime symptom frequency and severity, activity avoidance and limitation, asthma-related stress and fatigue as well as rescue asthma medication use) as measured by the Asthma Symptom Diary
  10. Change from baseline in Asthma Control Questionnaire (ACQ-6) at Week 48
  11. Change from baseline in Asthma Quality of Life Questionnaire (Standardised) + 12 at Week 48
  12. Change from baseline in European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsWindward Bio
Locations
WB Contracted Clinical Research Site | Los Angeles California, United States, 90025-7014WB Contracted Clinical Research Site | San Jose California, United States, 95117WB Contracted Clinical Research Site | Melbourne Florida, United States, 32763WB Contracted Clinical Research Site | Miami Florida, United States, 33175WB Contracted Clinical Research Site | White Marsh Maryland, United States, 21162WB Contracted Clinical Research Site | Stow Massachusetts, United States, 01775-1205WB Contracted Clinical Research Site | Detroit Michigan, United States, 48202-2608WB Contracted Clinical Research Site | Richfield Minnesota, United States, 55423-2477WB Contracted Clinical Research Site | St Louis Missouri, United States, 98119WB Contracted Clinical Research Site | Bellevue Nebraska, United States, 68123WB Contracted Clinical Research Site | Toledo Ohio, United States, 43560WB Contracted Clinical Research Site | Edmond Oklahoma, United States, 73034WB Contracted Clinical Research Site | Pittsburgh Pennsylvania, United States, 15213-3236WB Contracted Clinical Research Site | Charleston South Carolina, United States, 29420WB Contracted Clinical Research Site | Spartanburg South Carolina, United States, 29303WB Contracted Clinical Research Site | Austin Texas, United States, 78730WB Contracted Clinical Research Site | El Paso Texas, United States, 79903WB Contracted Clinical Research Site | McKinney Texas, United States, 75069-8085WB Contracted Clinical Research Site | San Antonio Texas, United States, 78229WB Contracted Clinical Research Site | Tyler Texas, United States, 75708-3154WB Contracted Clinical Research Site | Richmond Virginia, United States, 23226WB Contracted Clinical Research Site | Buenos Aires Buenos Aires F.D., Argentina, C1023AABWB Contracted Clinical Research Site | Buenos Aires Buenos Aires F.D., Argentina, C1121ABEWB Contracted Clinical Research Site | Buenos Aires Buenos Aires F.D., Argentina, C1414AIFWB Contracted Clinical Research Site | Buenos Aires Buenos Aires F.D., Argentina, C1425BENWB Contracted Clinical Research Site | Buenos Aires Buenos Aires F.D., Argentina, C1425FVHWB Contracted Clinical Research Site | Buenos Aires Buenos Aires F.D., Argentina, C1426ABPWB Contracted Clinical Research Site | Córdoba Córdoba Province, Argentina, X5003DCEWB Contracted Clinical Research Site | Paraná Entre Ríos Province, Argentina, E3102ADPWB Contracted Clinical Research Site | Rosario Santa Fe Province, Argentina, S2000BRHWB Contracted Clinical Research Site | Rosario Santa Fe Province, Argentina, S2013KZDWB Contracted Clinical Research Site | Santa Fe Santa Fe Province, Argentina, S3000ASFWB Contracted Clinical Research Site | San Miguel de Tucumán Tucumán Province, Argentina, T4000CBCWB Contracted Clinical Research Site | San Miguel de Tucumán Tucumán Province, Argentina, T4000IAPWB Contracted Clinical Research Site | San Miguel de Tucumán Tucumán Province, Argentina, T4000IFLWB Contracted Clinical Research Site | Brookvale New South Wales, Australia, 2100WB Contracted Clinical Research Site | Coffs Harbour New South Wales, Australia, 2450WB Contracted Clinical Research Site | Maroubra New South Wales, Australia, 2035WB Contracted Clinical Research Site | Miranda New South Wales, Australia, 2228WB Contracted Clinical Research Site | Wollongong New South Wales, Australia, 2500WB Contracted Clinical Research Site | Birtinya Queensland, Australia, 4575WB Contracted Clinical Research Site | North Altona Victoria, Australia, 3025WB Contracted Clinical Research Site | Sofia Grad Sofia, Bulgaria, 1407WB Contracted Clinical Research Site | Lovech Lovech, Bulgaria, 5500WB Contracted Clinical Research Site | Rousse Ruse, Bulgaria, 7000WB Contracted Clinical Research Site | Sofia Sofia, Bulgaria, 1233WB Contracted Clinical Research Site | Sofia Sofia, Bulgaria, 1680WB Contracted Clinical Research Site | Pessac Bordeaux, France, 33000WB Contracted Clinical Research Site | Dijon Côte-dOr, France, 21000WB Contracted Clinical Research Site | Montpellier Hérault, France, 34090WB Contracted Clinical Research Site | La Tronche Isère, France, 38700WB Contracted Clinical Research Site | Nantes Loire-Atlantique, France, 44093WB Contracted Clinical Research Site | Berlin Loire-Atlantique, Germany, 10119WB Contracted Clinical Research Site | München Loire-Atlantique, Germany, 80539WB Contracted Clinical Research Site | Bendorf Rhineland-Palatinate, Germany, 56170WB Contracted Clinical Research Site | Lübeck Schleswig-Holstein, Germany, 23552WB Contracted Clinical Research Site | Darmstadt , Germany, 64283WB Contracted Clinical Research Site | Frankfurt am Main , Germany, 60389WB Contracted Clinical Research Site | Frankfurt am Main , Germany, 60596WB Contracted Clinical Research Site | Leipzig , Germany, 4347WB Contracted Clinical Research Site | Mainz , Germany, 55128WB Contracted Clinical Research Site | München , Germany, 81241WB Contracted Clinical Research Site | Chiclana de la Frontera Cádiz, Spain, 11139WB Contracted Clinical Research Site | Madrid Entre Ríos, Spain, 28003WB Contracted Clinical Research Site | San Sebastián Guipúzcoa, Spain, 20014WB Contracted Clinical Research Site | Madrid Madrid, Spain, 28050WB Contracted Clinical Research Site | Pozuelo de Alarcón Madrid, Spain, 28223WB Contracted Clinical Research Site | Benalmádena Málaga, Spain, 29639WB Contracted Clinical Research Site | Málaga Málaga, Spain, 29010WB Contracted Clinical Research Site | Seville Sevilla, Spain, 41012WB Contracted Clinical Research Site | Linköping Ostergotlands, Sweden, 587 58WB Contracted Clinical Research Site | Malmo Skåne County, Sweden, 20512WB Contracted Clinical Research Site | Stockholm Stockholm County, Sweden, 11239
Investigators
Study Director: Omar Khwaja, MD, Windward Bio