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Taking people in BulgariaPhase 2

Tests WIN378 against placebo in adults with moderate or severe asthma

Tests the drug WIN378 against a placebo in adults with asthma.

Key facts

Who runs it
Windward Bio
Where
Haskovo, Lovech, Ruse, Sofia, Sofiya, and Varna, BulgariaSee the 7 sitesAlso in 7 other countries, 69 sites
Trial code
Registry title
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Status
Recruiting
Phase
Phase 2
People taking part
600 people, planned
Started
24 Jul 2025
Expected to end
23 Nov 2028
Type of study
Interventional, 2 groups
Treatments tested
  • WIN378
  • Placebo
Record updated
21 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate or severe asthma, who take regular asthma medicines, to test the drug WIN378 against placebo.

Age
18 to 75 years
Sex
All sexes can join. Women who can have children must use a highly effective contraception method.
Disease stage
Doctor-diagnosed asthma with proof of reversible airway narrowing. Part A: moderate to severe asthma. Part B: severe asthma that is not well controlled, with at least 2 asthma attacks (exacerbations) in the past 12 months.
Earlier treatment
Must already take inhaled steroids (ICS) plus at least 1 other regular asthma medicine (LABA/LTRA/LAMA/chromones/theophylline). Part A: low, medium or high dose ICS. Part B: medium or high dose ICS.
Biomarker or test result
Lung function test: pre-BD FEV1 of 30% to 90% of predicted in Part A, and 30% to 80% of predicted in Part B.

Main reasons for not taking part

  • Another important lung disease besides asthma
  • Tuberculosis, or tuberculosis treatment within the past 12 months
  • Current or former smoker with 10 pack years or more
  • History of cancer
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 with a known, pre-existing, clinically important lung condition other than asthma
  • Tuberculosis or treatment required for tuberculosis within 12 months
  • History of cancer
  • Current or former smokers ≥10 pack years
  • Participants who are pregnant, lactating or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Bulgaria

Also in 7 other countries, 69 sites

  • Medical Center Pulmo - 2018 EOODHaskovo, BulgariaTaking people
  • Medical Centre Pratia Clinic EOODLovech, BulgariaTaking people
  • Medical Center Prolet EOODRuse, BulgariaTaking people
  • Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EADSofia, BulgariaTaking people
  • Diagnostics And Consultation Center Convex Ltd.Sofiya, BulgariaTaking people
  • Medical Center Excelsior OODSofiya, BulgariaTaking people
  • Medical Center Research Expert OODVarna, BulgariaTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • WIN378Treatment being tested

    WIN378 SC injections

  • PlaceboTreatment being tested

    Placebo SC Injections

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests WIN378 against placebo in adults with moderate or severe asthmaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07120503, who can take part
Record updated
21 October 2026