Asthma study: WIN378
Official title Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
ClinicalTrials.gov ID: NCT07120503
What this study is testing
What is WIN378?
WIN378 is an investigational twice‑yearly injectable medicine being studied for asthma. WIN378 is designed to bind thymic stromal lymphopoietin (TSLP) and block its activity.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study has two parts. Part A will find the safest and most effective dose of WIN378. Part B will compare two doses of WIN378 with a placebo to see if it improves asthma symptoms and quality of life.
- Who it's for
- Adults who have moderate or severe asthma that is not well controlled.
- What's involved
- Participants will receive either WIN378 or a placebo in a double‑blind way. They will have regular clinic visits, lung function tests, and questionnaires about asthma control and quality of life.
- Time commitment
- The study lasts about 12 weeks, with several clinic visits for dosing, monitoring, and testing.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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
- Helminth infection within 24 weeks prior to screening
See the full eligibility 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
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Melbourne, Florida, United States
- Toledo, Ohio, United States
- McKinney, Texas, United States
- Buenos Aires, Buenos Aires F.D., Argentina
- Córdoba, Córdoba Province, Argentina
- Paraná, Entre Ríos Province, Argentina
- Santa Fe, Santa Fe Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Melbourne, Florida, United States; Toledo, Ohio, United States; McKinney, Texas, United States; Buenos Aires, Buenos Aires F.D., Argentina; Córdoba, Córdoba Province, Argentina; Paraná, Entre Ríos Province, Argentina and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.