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Active (not recruiting) Phase 2 NCT07120503

Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

Phase 2 – studying effectiveness and dosage
Conditions: Asthma (Diagnosis)

Sponsor: Windward Bio

trial.available_in: БГ
Overview
This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate or severe asthma. WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms. The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).
Description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy and pharmacokinetics of WIN378 in adult participants with moderate to severe asthma. Participants will continue their standard background asthma therapy according to GINA Steps 3-5. Eligible participants will be randomized to receive WIN378 or placebo administered subcutaneously over a 48-week treatment period, followed by a 12-week safety follow-up.
Who can participate
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 of ≥ 30% and ≤ 90%, predicted at two visits at Screening * Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline) Exclusion Criteria: * Participants with a known, pre-existing, clinically important lung condition other than asthma * Active 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
Locations 8
Argentina (1)
WB Contracted Clinical Research Site
Buenos Aires , Buenos Aires F.D.
Australia (1)
WB Contracted Clinical Research Site
Brookvale , New South Wales
Bulgaria (1)
WB Contracted Clinical Research Site
Sofia , Grad Sofia
France (1)
WB Contracted Clinical Research Site
Pessac , Bordeaux
Germany (1)
WB Contracted Clinical Research Site
Berlin , Loire-Atlantique
Spain (1)
WB Contracted Clinical Research Site
Chiclana de la Frontera , Cádiz
Sweden (1)
WB Contracted Clinical Research Site
Linköping , Ostergotlands
United States (1)
WB Contracted Clinical Research Site
Los Angeles , California
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
24.07.2025
Completion date
01.10.2027
Registry ID
NCT07120503
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.