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

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Status and phase: Enrolling; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: WIN378

Study type: Interventional

Funder types: Industry

Identifiers

NCT07120503

WB-2101

2025-521391-58-00 (EU Trial (CTIS) Number)

U1111-1319-6369 (Other Identifier)

2025

Details and patient eligibility

About

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.

Full description

The main purpose of this global study is to assess whether WIN378, an ultra-long-acting medicine for people with asthma, reduces the annualized rate of asthma exacerbations using the doses identified from an interim analysis of Part A of the study. WIN378 blocks the action of a protein called TSLP, which causes inflammation in the lung and may contribute to asthma control and symptoms. The study has two parts. Part A is evaluating three doses of WIN378 in adults with moderate or severe asthma to evaluate: 1) how WIN378 is handled by your body (pharmacokinetics), 2) the safety of WIN378 and 3) efficacy (markers of asthma inflammation (in your breath and in your blood), lung function and asthma control. An interim analysis of Part A data was used to select two doses of WIN378 for Part B. Part B will compare the two selected doses of WIN378 with placebo in adults with severe uncontrolled asthma. The main purpose of Part B is to assess whether WIN378 reduces the annualized rate of asthma exacerbations. In addition, it aims to evaluate whether WIN378 can improve lung function, quality of life, asthma control and other important efficacy measures. Furthermore the study will evaluate the safety and tolerability of WIN378 versus placebo.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

WIN378

Experimental group

Description:

WIN378 SC injections

Treatment:

Drug: WIN378

Placebo

Experimental group

Description:

Placebo SC Injections

Treatment:

Drug: Placebo