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

Not Applicable

Recruiting

• Conditions: Asthma (Diagnosis)
• Interventions: Drug: WIN378; Drug: Placebo

• Registration Number: NCT07120503
• Lead Sponsor: Windward Bio

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 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).

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 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.

Study Timeline

• Study Start: 2025-07-24
• Study First Submitted: 2025-07-25
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2027-07
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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 in prior 24 months
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WIN378	WIN378	WIN378 SC injections
Placebo	Placebo	Placebo SC Injections

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in FeNO at Week 24 and Week 48	Week 0 - Week 24, Week 48
Change from Baseline in Blood eosinophil count at Week 24 and Week 48	Week 0 - Week 24, Week 48
Change in pre-BD and post-BD FEV1 at Week 24 and Week 48	Week 0 - Week 24, Week 48
Change in pre-BD and post-BD forced vital capacity (FVC) at Week 24 and Week 48	Week 0 - Week 24, Week 48
Annualized asthma exacerbation rate (AAER) over 48 weeks	Week 0 - Week 48
Annualized rate of severe asthma exacerbations over 48 weeks	Week 0 - Week 48
Time to first asthma exacerbation/severe asthma exacerbation over 48 weeks	Week 0 - Week 48
Proportion of participants with 1 or more asthma exacerbations/severe asthma exacerbations over 48 weeks	Week 0 - Week 48
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	Week 0 - Week 48
Change from baseline in Asthma Control Questionnaire (ACQ-6) at Week 48	Week 0 - Week 48
Change from baseline in Asthma Quality of Life Questionnaire (Standardised) + 12 at Week 48	Week 0 - Week 48
Change from baseline in European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48	Week 0 - Week 48

Trial Locations

Locations (1)

WB Contracted Clinical Research Site; 🇺🇸 Richmond, Virginia, United States