Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Seve… (NCT07120503) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
United States, Argentina, Australia136 participantsStarted 2025-07-24
Plain-language summary
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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-emergent adverse events (TEAEs) during the study
Timeframe: Week 0 - Week 60
2
Number of participants with treatment-emergent serious adverse events (TESAEs) during the study
Timeframe: Week 0 - Week 60
3
Number of participants with abnormal vital signs during the study
Timeframe: Week 0 - Week 60
4
Number of participants with abnormal laboratory assessments during the study
Timeframe: Week 0 - Week 60
5
Number of participants with Clinically significant abnormal ECG results during the study
Timeframe: Week 0 - Week 60
6
WIN 378 Pharmacokinetics: concentration at trough [Ctrough]
Timeframe: Week 0 - Week 60
7
WIN 378 Pharmacokinetics: area under the concentration time curve [AUC]