Recruiting
Phase 2

WIN378

Sponsor:

Windward Bio

Code:

NCT07120503

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

WIN378

Placebo

Study Details

Brief 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.

Conditions

Asthma

Study ID

NCT07120503

Start date

Jul 24, 2025

Status verified date

Oct, 2026

Completion date

Nov 23, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: WIN378

WIN378 SC injections

experimental: Placebo

Placebo SC Injections

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ayshea Kring

+41 61 551 71 39clinical.trial.enquiry@windwardbio.com

Locations

WB Contracted Clinical Research Site

Recruiting

Melbourne, Florida, United States, 32763

WB Contracted Clinical Research Site

Recruiting

Toledo, Ohio, United States, 43560

WB Contracted Clinical Research Site

Recruiting

McKinney, Texas, United States, 75069-8085

More Information

Sponsor

Windward Bio

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

  • Asthma
  • Moderate Asthma
  • Severe Asthma
  • Uncontrolled Asthma
  • Respiratory Diseases
  • Lung Diseases
  • Bronchial Diseases
  • Allergic Diseases
  • Biologic Therapy
  • Anti-TSLP
  • TSLP inhibitor
  • monoclonal antibody
  • ultra-long-acting biologic
  • ultra-long-acting monoclonal antibody
  • Thymic stromal lymphopoietin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Windward Bio on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.