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

RecruitingPhase 2Ages 18 Years - 75 YearsAllWindward Bio
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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: PART A of โ‰ฅ 30% and โ‰ค 90%, predicted; PART B of โ‰ฅ 30% and โ‰ค 80%, predicted * PART A Low, medium-, or high-dose ICS and โ‰ฅ1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline) * PART B: medium-, or high-dose ICS and โ‰ฅ1 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 Criteria: * Participants with a known, pre-existing, clinically important lung condition other than asthma * Tuberculosis or treatment required for tuberculosis within 12 months * Current or former smokers โ‰ฅ10 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
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What it tests

  • WIN378
  • Placebo
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Where

73 sites
WB Contracted Clinical Research Site
Los Angeles, United States
WB Contracted Clinical Research Site
San Jose, United States
WB Contracted Clinical Research Site
Melbourne, United States
WB Contracted Clinical Research Site
Miami, United States
WB Contracted Clinical Research Site
White Marsh, United States
WB Contracted Clinical Research Site
Stow, United States
WB Contracted Clinical Research Site
Detroit, United States
WB Contracted Clinical Research Site
Richfield, United States

โ€ฆand 65 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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