WIN378 in Adults with Moderate to Severe Asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global Phase 2 program explores WIN378, an ultra-long-acting therapy that blocks TSLP, in adults with asthma. Part A is a double-blind, randomized dose-range finding study to identify safe and effective doses and gather pharmacokinetic and biomarker data. Part B is a pivotal double-blind, randomized trial comparing two doses of WIN378 to placebo in adults with severe uncontrolled asthma to assess annual asthma exacerbations, lung function, quality of life, and other efficacy and safety endpoints. The study evaluates whether the selected WIN378 doses can reduce exacerbations and improve asthma control, with safety/tolerability monitored throughout.

Why it matters

Who can join: the full rules

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

Where it's running

• WB Contracted Clinical Research Site
  Melbourne, Florida, United States Recruiting
• WB Contracted Clinical Research Site
  Toledo, Ohio, United States Recruiting
• WB Contracted Clinical Research Site
  McKinney, Texas, United States Recruiting
• WB Contracted Clinical Research Site
  Buenos Aires, Buenos Aires F.D., Argentina Recruiting
• WB Contracted Clinical Research Site
  Buenos Aires, Buenos Aires F.D., Argentina Recruiting
• WB Contracted Clinical Research Site
  Córdoba, Córdoba Province, Argentina Recruiting

+23 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Ayshea Kring
• Email: clinical.trial.enquiry@windwardbio.com
• Phone: +41 61 551 71 39

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• HB0056 in adults with moderate to severe asthma

  This study tests HB0056 versus a placebo to see if it helps adults with moderate to severe asthma reduce rescue inhaler use and improve symptoms.

  Recruiting at 2 sites Phase 1/2 Shanghai Huaota Biopharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07899996

• Tilrekimig (PF-07275315) for Severe Asthma: Aimed at Adults with Frequent Exacerbations

  This study tests whether tilrekimig helps people with severe asthma who have had multiple flare-ups in the past year, by comparing it to a placebo given every four weeks.

  Recruiting at 4 sites Phase 3 Pfizer · River Forest, Illinois and 11 other locations · NCT07869043

• Inhaled CHF10136 safety and pharmacokinetics in healthy adults and adults with asthma

  This first-in-human study tests inhaled CHF10136 to see if it is safe and well tolerated, how it behaves in the body, and how it affects adults with asthma compared with placebo.

  Recruiting Phase 1 Chiesi Farmaceutici S.p.A. · Leeds and 2 other locations · NCT07851623

• Biologics for Type 2 Inflammation in Asthma and COPD in Real World

  This real-world study tests whether six biologic drugs can reduce flare-ups and improve symptoms in adults with asthma or COPD treated in routine care in China.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07823842

• GSK5784283 vs placebo in uncontrolled asthma (PERSIST ASTHMA-2)

  A new medicine called GSK5784283 is being tested to see if it lowers asthma flare-ups better than a placebo in people with uncontrolled asthma.

  Recruiting at 7 sites Phase 3 GlaxoSmithKline · San Diego, California and 6 other locations · NCT07782996

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.