Tests WIN378 against placebo in adults with moderate or severe asthma
Tests the drug WIN378 against a placebo in adults with asthma.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Key facts
- Where
- Bendorf, Berlin, Darmstadt, Frankfurt am Main, Hanover, Leipzig, Luebeck, Mainz, München, Neu-Isenburg, and Wiesbaden, GermanySee the 13 sites
- Phase
- Phase 2
Could this be for you?
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?
Source: NCT07120503, who can take part
Where in Germany
- KPPK GmbHBendorf, GermanyTaking people
- Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbRBerlin, GermanyTaking people
- Pneumo Studien Darmstadt GmbHDarmstadt, GermanyTaking people
- IKF Pneumologie GmbH & Co. KGFrankfurt am Main, GermanyTaking people
- Studienzentrum Dr. Claus KellerFrankfurt am Main, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- POIS Sachsen GmbHLeipzig, GermanyTaking people
- Velocity Clinical Research Germany GmbHLuebeck, GermanyTaking people
- IKF Pneumologie GmbH & Co. KGMainz, GermanyTaking people
- Pneumologisches Studienzentrum München-WestMünchen, GermanyTaking people
- Praxis Dr. med. Jan FeimerMünchen, GermanyTaking people
- Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbHNeu-Isenburg, GermanyTaking people
- Lungenfacharztzentrum Wiesbaden BAGWiesbaden, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Windward Bio
- Trial code
- NCT07120503EU 2025-521391-58-00
- Record updated
- 21 October 2026
- Original description
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
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
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.
Inclusion: 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: 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.