RightFit
RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of WIN378, how it works in the body, and how well it treats asthma in adults. Part A tests doses in adults with moderate or severe asthma. Part B compares two doses with a placebo (a treatment with no active drug) in adults with severe asthma that is not well controlled.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a form agreeing to join the study.
  • Women must not be pregnant or breastfeeding. Those who can become pregnant must use highly effective birth control.
  • Have asthma diagnosed by a doctor, with test results showing that narrowed airways can open up, from the past 24 months or during screening.
  • Have a breathing test result before airway-opening medicine of 30%–90% of the expected value for Part A, or 30%–80% for Part B.
  • For Part A, use a low-, medium-, or high-dose inhaled steroid and at least one other regular asthma control medicine.
  • For Part B, use a medium- or high-dose inhaled steroid and at least one other regular asthma control medicine.
  • For Part B, have had at least two asthma flare-ups in the 12 months before the first visit.

Who can't join

  • Have another important lung condition besides asthma.
  • Have tuberculosis (TB), or have needed TB treatment within the past 12 months.
  • Currently smoke or used to smoke, with a total of at least 10 pack-years (such as one pack a day for 10 years).
  • Have a history of cancer.
  • Recently received a biologic drug (within 4 months or five drug half-lives—the time it takes half a drug to leave the body); immune proteins or blood products (within 30 days before screening or during the screening period); or a live or weakened-virus vaccine (within 15 days before screening).
  • Had a parasitic worm infection within 24 weeks before screening.
  • Used medicine that weakens the immune system within 3 months before screening or during the screening period.
  • Are pregnant, making breast milk, or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 ≥ 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 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 ≥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

Study sites (21)

CA

FL

MA

MD

MI

MN

MO

NE

OH

OK

PA

SC

TX

VA