NCT07120503|RecruitingPhase 2FDA Drug

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

A 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

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3 other identifiers

WB-21012025-521391-58-00U1111-1319-6369

Study Type

interventional

Target

136

Locations

8 countries

Sites

Timeline

RegisteredAug 2025

StartedJul 2025

CompletionOct 2027

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

136

participants targeted

Target at P75+ for phase_2

Timeline

17mo left

Started Jul 2025

Geographic Reach

8 countries

64 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Progress36%

Jul 2025Oct 2027

Study Start

First participant enrolled

July 24, 2025

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed

19 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

July 25, 2025

Last Update Submit

February 20, 2026

Conditions

Asthma (Diagnosis)

Keywords

AsthmaModerate AsthmaSevere AsthmaUncontrolled AsthmaRespiratory DiseasesLung DiseasesBronchial DiseasesAllergic Diseases

Outcome Measures

Primary Outcomes (9)

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 Outcomes (12)

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
+7 more secondary outcomes

Study Arms (2)

WIN378

EXPERIMENTAL

WIN378 SC injections

Drug: WIN378

Placebo

EXPERIMENTAL

Placebo SC Injections

Drug: Placebo

Interventions

WIN378DRUG

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.

WIN378

PlaceboDRUG

A sham injection consisting of placebo to mask WIN378.

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.