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
Sites (71)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | Paraná | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | Rosario | Argentina | Active, not recruiting |
| - Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Santa Fe | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | Birtinya | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Brookvale | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Maroubra | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Miranda | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | North Altona | Australia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Wollongong | Australia | Active, not recruiting |
| Medical Center Pulmo - 2018 EOOD Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Recruiting |
| Medical Centre Pratia Clinic EOOD Coordinator of this site? Confirm its status | Lovech | Bulgaria | Recruiting |
| Medical Center Prolet EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Recruiting |
| Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Medical Center Excelsior OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Medical Center Research Expert OOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Recruiting |
| KPPK GmbH Coordinator of this site? Confirm its status | Bendorf | Germany | Recruiting |
| Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Pneumo Studien Darmstadt GmbH Coordinator of this site? Confirm its status | Darmstadt | Germany | Recruiting |
| Studienzentrum Dr. Claus Keller Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| POIS Sachsen GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Velocity Clinical Research Germany GmbH Coordinator of this site? Confirm its status | Luebeck | Germany | Recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Praxis Dr. med. Jan Feimer Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Pneumologisches Studienzentrum München-West Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH Coordinator of this site? Confirm its status | Neu-Isenburg | Germany | Recruiting |
| Lungenfacharztzentrum Wiesbaden BAG Coordinator of this site? Confirm its status | Wiesbaden | Germany | Recruiting |
| Hospital Vithas Xanit Internacional Coordinator of this site? Confirm its status | Benalmádena | Spain | Recruiting |
| Futuremeds Spain S.L. Coordinator of this site? Confirm its status | Chiclana De La Frontera | Spain | Recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Futuremeds Spain S.L. Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Futuremeds Spain S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Cordinator Medical Service AB Coordinator of this site? Confirm its status | Linkoping | Sweden | Completed |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Completed |
| MediTrials AB Coordinator of this site? Confirm its status | Malmo | Sweden | Completed |
| Halsoklustret AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
| - Coordinator of this site? Confirm its status | Austin | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Bellevue | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Charleston | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Detroit | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Edmond | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | El Paso | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | McKinney | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Melbourne | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Miami | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Pittsburgh | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Richfield | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Richmond | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | San Antonio | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | San Jose | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Spartanburg | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | St Louis | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Stow | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Tyler | United States | Active, not recruiting |
| - Coordinator of this site? Confirm its status | White Marsh | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.