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NCT07120503RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
600 (estimated)
First submitted
25 Jul 2025
Start date
Jul 2025
Primary completion date
Oct 2028
Lead sponsor
Windward Bio
Diseases
Asthma
NCT number
NCT07120503
EU CT number
2025-521391-58-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 600
  • From Jul 2025 to the primary completion date, Oct 2028
  • 71 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Current or former smokers ≥10 pack years
  • Participants who are pregnant, lactating or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaActive, not recruiting
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CórdobaArgentinaRecruiting
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ParanáArgentinaRecruiting
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RosarioArgentinaActive, not recruiting
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San Miguel de TucumánArgentinaActive, not recruiting
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Santa FeArgentinaRecruiting
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BirtinyaAustraliaActive, not recruiting
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BrookvaleAustraliaActive, not recruiting
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Coffs HarbourAustraliaActive, not recruiting
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MaroubraAustraliaActive, not recruiting
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MirandaAustraliaActive, not recruiting
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North AltonaAustraliaActive, not recruiting
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WollongongAustraliaActive, not recruiting
Medical Center Pulmo - 2018 EOOD
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HaskovoBulgariaRecruiting
Medical Centre Pratia Clinic EOOD
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LovechBulgariaRecruiting
Medical Center Prolet EOOD
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RuseBulgariaRecruiting
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
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SofiaBulgariaRecruiting
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaRecruiting
Medical Center Excelsior OOD
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SofiyaBulgariaRecruiting
Medical Center Research Expert OOD
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VarnaBulgariaRecruiting
KPPK GmbH
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BendorfGermanyRecruiting
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
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BerlinGermanyRecruiting
Pneumo Studien Darmstadt GmbH
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DarmstadtGermanyRecruiting
Studienzentrum Dr. Claus Keller
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Frankfurt am MainGermanyRecruiting
IKF Pneumologie GmbH & Co. KG
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Frankfurt am MainGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
POIS Sachsen GmbH
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LeipzigGermanyRecruiting
Velocity Clinical Research Germany GmbH
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LuebeckGermanyRecruiting
IKF Pneumologie GmbH & Co. KG
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MainzGermanyRecruiting
Praxis Dr. med. Jan Feimer
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MünchenGermanyRecruiting
Pneumologisches Studienzentrum München-West
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MünchenGermanyRecruiting
Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH
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Neu-IsenburgGermanyRecruiting
Lungenfacharztzentrum Wiesbaden BAG
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WiesbadenGermanyRecruiting
Hospital Vithas Xanit Internacional
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BenalmádenaSpainRecruiting
Futuremeds Spain S.L.
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Chiclana De La FronteraSpainRecruiting
Hospital Universitario Donostia
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DonostiaSpainRecruiting
Hospital Universitario HM Sanchinarro
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MadridSpainRecruiting
Futuremeds Spain S.L.
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Futuremeds Spain S.L.
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SevillaSpainRecruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Cordinator Medical Service AB
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LinkopingSwedenCompleted
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
MediTrials AB
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MalmoSwedenCompleted
Halsoklustret AB
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StockholmSwedenCompleted
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AustinUnited StatesActive, not recruiting
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BellevueUnited StatesActive, not recruiting
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CharlestonUnited StatesActive, not recruiting
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DetroitUnited StatesActive, not recruiting
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EdmondUnited StatesActive, not recruiting
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El PasoUnited StatesActive, not recruiting
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Los AngelesUnited StatesActive, not recruiting
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McKinneyUnited StatesRecruiting
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MelbourneUnited StatesRecruiting
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MiamiUnited StatesActive, not recruiting
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PittsburghUnited StatesActive, not recruiting
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RichfieldUnited StatesActive, not recruiting
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RichmondUnited StatesActive, not recruiting
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San AntonioUnited StatesActive, not recruiting
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San JoseUnited StatesActive, not recruiting
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SpartanburgUnited StatesActive, not recruiting
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St LouisUnited StatesActive, not recruiting
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StowUnited StatesActive, not recruiting
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ToledoUnited StatesRecruiting
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TylerUnited StatesActive, not recruiting
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White MarshUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.