A Phase 2 interventional study of WIN378 and Placebo in Asthma, sponsored by Windward Bio. Recruiting at 73 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Windward Bio · Phase 2, Interventional, and Treatment
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.
The main purpose of this global study is to assess whether WIN378, an ultra-long-acting medicine for people with asthma, reduces the annualized rate of asthma exacerbations using the doses identified from an interim analysis of Part A of the study. WIN378 blocks the action of a protein called TSLP, which causes inflammation in the lung and may contribute to asthma control and symptoms. The study has two parts. Part A is evaluating three doses of WIN378 in adults with moderate or severe asthma to evaluate: 1) how WIN378 is handled by your body (pharmacokinetics), 2) the safety of WIN378 and 3) efficacy (markers of asthma inflammation (in your breath and in your blood), lung function and asthma control. An interim analysis of Part A data was used to select two doses of WIN378 for Part B. Part B will compare the two selected doses of WIN378 with placebo in adults with severe uncontrolled asthma. The main purpose of Part B is to assess whether WIN378 reduces the annualized rate of asthma exacerbations. In addition, it aims to evaluate whether WIN378 can improve lung function, quality of life, asthma control and other important efficacy measures. Furthermore the study will evaluate the safety and tolerability of WIN378 versus placebo.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 600 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Windward Bio is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 21, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
WIN378 SC injections
Drug: WIN378
Placebo SC Injections
Drug: Placebo
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.
A sham injection consisting of placebo to mask WIN378.
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
PART A,B: Change from baseline in FeNO at Week 24 and Week 48
Time frame: Week 0 - Week 24, Week 48
PART A,B: Change from Baseline in Blood eosinophil count at Week 24 and Week 48
Time frame: Week 0 - Week 24, Week 48
PART A,B: Change in pre-BD and post-BD FEV1 at Week 24 and Week 48
Time frame: Week 0 - Week 24, Week 48
PART A: Change in pre-BD and post-BD forced vital capacity (FVC) at Week 24 and Week 48
Time frame: Week 0 - Week 24, Week 48
PART A Annualized asthma exacerbation rate (AAER) over 48 weeks
Time frame: Week 0 - Week 48
PART A Annualized rate of severe asthma exacerbations over 48 weeks
Time frame: Week 0 - Week 48
PART A,B:Time to first asthma exacerbation/severe asthma exacerbation over 48 weeks
Time frame: Week 0 - Week 48
PART A,B: Proportion of participants without any asthma exacerbations/severe asthma exacerbations over 48 weeks
Time frame: Week 0 - Week 48
PART A Change from baseline in asthma symptoms (daytime and nighttime symptom frequency and severity, activity avoidance and limitation, asthma-related stress and fatigue as well as rescue asthma medication use) as measured by the Asthma Symptom Diary
Time frame: Week 0 - Week 48
PART A,B: Change from baseline in Asthma Control Questionnaire (ACQ-6) at Week 48
Time frame: Week 0 - Week 48
PART A,B: Change from baseline in Asthma Quality of Life Questionnaire (Standardised) + 12 at Week 48
Time frame: Week 0 - Week 48
PART A,B: Change from baseline in European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48
Time frame: Week 0 - Week 48
PART B: Change from baseline in Patient Global Impression of Change at Week 48
Time frame: Week 0 - Week 48
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Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Oct 2028, 38 months after the start.
Of 137 industry-sponsored phase 2 interventional studies under Asthma, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's planned 38 months is above that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: primary completion Jul 2027 → Oct 2028 and completion Oct 2027 → Nov 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
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