NCT07120503 · Windward Bio
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
WIN378
WIN378 is a fully human, ultra-long-acting monoclonal antibody given twice-yearly that binds to thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving asthma control over the extended dosing interval.
DRUG
Placebo
A sham injection consisting of placebo to mask WIN378.
Primary outcome measures
PART A: Number of participants with treatment-emergent adverse events (TEAEs) during the study
Time frame: Week 0 - Week 60
PART A: Number of participants with treatment-emergent serious adverse events (TESAEs) during the study
Time frame: Week 0 - Week 60
PART A: Number of participants with abnormal vital signs during the study
Time frame: Week 0 - Week 60
PART A: Number of participants with abnormal laboratory assessments during the study
Time frame: Week 0 - Week 60
PART A: Number of participants with Clinically significant abnormal ECG results during the study
Time frame: Week 0 - Week 60
PART A: WIN 378 Pharmacokinetics: concentration at trough [Ctrough]
Time frame: Week 0 - Week 60
PART A: WIN 378 Pharmacokinetics: area under the concentration time curve [AUC]
Time frame: Week 0 - Week 60
PART A: WIN 378 Pharmacokinetics: maximum observed concentration [Cmax])
Time frame: Week 0 - Week 60
PART A: Number of participants with positive anti-drug antibodies (ADA) during the study
Time frame: Week 0 - Week 60
PART B: Annualized Asthma Exacerbation Rate (AAER)
Time frame: 24 Weeks after last dose
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- San Jose, California
- Melbourne, Florida
- Miami, Florida
- White Marsh, Maryland
- Stow, Massachusetts
- Detroit, Michigan
- Richfield, Minnesota
- St Louis, Missouri
- Bellevue, Nebraska
- Toledo, Ohio
- Edmond, Oklahoma
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 21, 2026 · Source of record for eligibility and locations