AsthmaPhase 2PolarisNCT07120503
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
A Phase 2 study testing WIN378 in people with Asthma, run by Windward Bio at 73 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- WIN378
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 73 sitesin 8 countries
- Study dates
- 24 Jul 2025to 23 Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
73 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
73 sites in 8 countries
United States21 sites, 3 recruiting
- Active, not recruiting
WB Contracted Clinical Research Site
Austin, Texas, 78730
- Active, not recruiting
WB Contracted Clinical Research Site
Bellevue, Nebraska, 68123
- Active, not recruiting
WB Contracted Clinical Research Site
Charleston, South Carolina, 29420
- Active, not recruiting
WB Contracted Clinical Research Site
Detroit, Michigan, 48202-2608
- Active, not recruiting
WB Contracted Clinical Research Site
Edmond, Oklahoma, 73034
- Active, not recruiting
WB Contracted Clinical Research Site
El Paso, Texas, 79903
- Active, not recruiting
WB Contracted Clinical Research Site
Los Angeles, California, 90025-7014
- Recruiting
WB Contracted Clinical Research Site
McKinney, Texas, 75069-8085
- Recruiting
WB Contracted Clinical Research Site
Melbourne, Florida, 32763
- Active, not recruiting
WB Contracted Clinical Research Site
Miami, Florida, 33175
- Active, not recruiting
WB Contracted Clinical Research Site
Pittsburgh, Pennsylvania, 15213-3236
- Active, not recruiting
WB Contracted Clinical Research Site
Richfield, Minnesota, 55423-2477
- Active, not recruiting
WB Contracted Clinical Research Site
Richmond, Virginia, 23226
- Active, not recruiting
WB Contracted Clinical Research Site
San Antonio, Texas, 78229
- Active, not recruiting
WB Contracted Clinical Research Site
San Jose, California, 95117
- Active, not recruiting
WB Contracted Clinical Research Site
Spartanburg, South Carolina, 29303
- Active, not recruiting
WB Contracted Clinical Research Site
St Louis, Missouri, 98119
- Active, not recruiting
WB Contracted Clinical Research Site
Stow, Massachusetts, 01775-1205
- Recruiting
WB Contracted Clinical Research Site
Toledo, Ohio, 43560
- Active, not recruiting
WB Contracted Clinical Research Site
Tyler, Texas, 75708-3154
- Active, not recruiting
WB Contracted Clinical Research Site
White Marsh, Maryland, 21162
Argentina14 sites, 6 recruiting
- Active, not recruiting
WB Contracted Clinical Research Site
Buenos Aires, Buenos Aires F.D., C1023AAB
- Active, not recruiting
WB Contracted Clinical Research Site
Buenos Aires, Buenos Aires F.D., C1121ABE
- Recruiting
WB Contracted Clinical Research Site
Buenos Aires, Buenos Aires F.D., C1414AIF
- Recruiting
WB Contracted Clinical Research Site
Buenos Aires, Buenos Aires F.D., C1425BEN
- Active, not recruiting
WB Contracted Clinical Research Site
Buenos Aires, Buenos Aires F.D., C1425FVH
- Active, not recruiting
WB Contracted Clinical Research Site
Buenos Aires, Buenos Aires F.D., C1426ABP
- Recruiting
WB Contracted Clinical Research Site
Córdoba, Córdoba Province, X5003DCE
- Recruiting
WB Contracted Clinical Research Site
Paraná, Entre Ríos Province, E3102ADP
- Active, not recruiting
WB Contracted Clinical Research Site
Rosario, Santa Fe Province, S2000BRH
- Active, not recruiting
WB Contracted Clinical Research Site
Rosario, Santa Fe Province, S2013KZD
- Active, not recruiting
WB Contracted Clinical Research Site
San Miguel de Tucumán, Tucumán Province, T4000CBC
- Active, not recruiting
WB Contracted Clinical Research Site
San Miguel de Tucumán, Tucumán Province, T4000IAP
- Recruiting
WB Contracted Clinical Research Site
San Miguel de Tucumán, Tucumán Province, T4000IFL
- Recruiting
WB Contracted Clinical Research Site
Santa Fe, Santa Fe Province, S3000ASF
Germany10 sites
- Active, not recruiting
WB Contracted Clinical Research Site
Bendorf, Rhineland-Palatinate, 56170
- Active, not recruiting
WB Contracted Clinical Research Site
Berlin, Loire-Atlantique, 10119
- Active, not recruiting
WB Contracted Clinical Research Site
Darmstadt, 64283
- Active, not recruiting
WB Contracted Clinical Research Site
Frankfurt am Main, 60389
- Active, not recruiting
WB Contracted Clinical Research Site
Frankfurt am Main, 60596
- Active, not recruiting
WB Contracted Clinical Research Site
Leipzig, 4347
- Active, not recruiting
WB Contracted Clinical Research Site
Lübeck, Schleswig-Holstein, 23552
- Active, not recruiting
WB Contracted Clinical Research Site
Mainz, 55128
- Active, not recruiting
WB Contracted Clinical Research Site
München, Loire-Atlantique, 80539
- Active, not recruiting
WB Contracted Clinical Research Site
München, 81241
Spain8 sites
- Active, not recruiting
WB Contracted Clinical Research Site
Benalmádena, Málaga, 29639
- Active, not recruiting
WB Contracted Clinical Research Site
Chiclana de la Frontera, Cádiz, 11139
- Active, not recruiting
WB Contracted Clinical Research Site
Madrid, Entre Ríos, 28003
- Active, not recruiting
WB Contracted Clinical Research Site
Madrid, Madrid, 28050
- Active, not recruiting
WB Contracted Clinical Research Site
Málaga, Málaga, 29010
- Active, not recruiting
WB Contracted Clinical Research Site
Pozuelo de Alarcón, Madrid, 28223
- Active, not recruiting
WB Contracted Clinical Research Site
San Sebastián, Guipúzcoa, 20014
- Active, not recruiting
WB Contracted Clinical Research Site
Seville, Sevilla, 41012
Australia7 sites
- Active, not recruiting
WB Contracted Clinical Research Site
Birtinya, Queensland, 4575
- Active, not recruiting
WB Contracted Clinical Research Site
Brookvale, New South Wales, 2100
- Active, not recruiting
WB Contracted Clinical Research Site
Coffs Harbour, New South Wales, 2450
- Active, not recruiting
WB Contracted Clinical Research Site
Maroubra, New South Wales, 2035
- Active, not recruiting
WB Contracted Clinical Research Site
Miranda, New South Wales, 2228
- Active, not recruiting
WB Contracted Clinical Research Site
North Altona, Victoria, 3025
- Active, not recruiting
WB Contracted Clinical Research Site
Wollongong, New South Wales, 2500
Bulgaria5 sites
- Active, not recruiting
WB Contracted Clinical Research Site
Lovech, Lovech, 5500
- Active, not recruiting
WB Contracted Clinical Research Site
Rousse, Ruse, 7000
- Active, not recruiting
WB Contracted Clinical Research Site
Sofia, Grad Sofia, 1407
- Active, not recruiting
WB Contracted Clinical Research Site
Sofia, Sofia, 1233
- Active, not recruiting
WB Contracted Clinical Research Site
Sofia, Sofia, 1680
France5 sites
- Active, not recruiting
WB Contracted Clinical Research Site
Dijon, Côte-dOr, 21000
- Active, not recruiting
WB Contracted Clinical Research Site
La Tronche, Isère, 38700
- Active, not recruiting
WB Contracted Clinical Research Site
Montpellier, Hérault, 34090
- Active, not recruiting
WB Contracted Clinical Research Site
Nantes, Loire-Atlantique, 44093
- Active, not recruiting
WB Contracted Clinical Research Site
Pessac, Bordeaux, 33000
Sweden3 sites
- Active, not recruiting
WB Contracted Clinical Research Site
Linköping, Ostergotlands, 587 58
- Active, not recruiting
WB Contracted Clinical Research Site
Malmö, Skåne County, 20512
- Active, not recruiting
WB Contracted Clinical Research Site
Stockholm, Stockholm County, 11239
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Asthma
- Being tested
- WIN378, Placebo
- Keywords
- Asthma, Moderate Asthma, Severe Asthma, Uncontrolled Asthma, Respiratory Diseases, Lung Diseases, Bronchial Diseases, Allergic Diseases, Biologic Therapy, Anti-TSLP, TSLP inhibitor, monoclonal antibody, ultra-long-acting biologic, ultra-long-acting monoclonal antibody, Thymic stromal lymphopoietin
- Medical subject headings
- Asthma, Respiratory Tract Diseases, Lung Diseases, Bronchial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIN378Drug
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.
PlaceboDrug
A sham injection consisting of placebo to mask WIN378.
| Study group | Role | What they receive |
|---|---|---|
| WIN378 | Experimental | WIN378 SC injections Receives: Drug: WIN378 |
| Placebo | Experimental | Placebo SC Injections Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PART A: Number of participants with treatment-emergent adverse events (TEAEs) during the study
Measured: Week 0 - Week 60
PART A: Number of participants with treatment-emergent serious adverse events (TESAEs) during the study
Measured: Week 0 - Week 60
PART A: Number of participants with abnormal vital signs during the study
Measured: Week 0 - Week 60
PART A: Number of participants with abnormal laboratory assessments during the study
Measured: Week 0 - Week 60
PART A: Number of participants with Clinically significant abnormal ECG results during the study
Measured: Week 0 - Week 60
PART A: WIN 378 Pharmacokinetics: concentration at trough [Ctrough]
Measured: Week 0 - Week 60
PART A: WIN 378 Pharmacokinetics: area under the concentration time curve [AUC]
Measured: Week 0 - Week 60
PART A: WIN 378 Pharmacokinetics: maximum observed concentration [Cmax])
Measured: Week 0 - Week 60
PART A: Number of participants with positive anti-drug antibodies (ADA) during the study
Measured: Week 0 - Week 60
PART B: Annualized Asthma Exacerbation Rate (AAER)
Measured: 24 Weeks after last dose
Secondary outcomes (13)
PART A,B: Change from baseline in FeNO at Week 24 and Week 48
Measured: Week 0 - Week 24, Week 48
PART A,B: Change from Baseline in Blood eosinophil count at Week 24 and Week 48
Measured: Week 0 - Week 24, Week 48
PART A,B: Change in pre-BD and post-BD FEV1 at Week 24 and Week 48
Measured: 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
Measured: Week 0 - Week 24, Week 48
PART A Annualized asthma exacerbation rate (AAER) over 48 weeks
Measured: Week 0 - Week 48
PART A Annualized rate of severe asthma exacerbations over 48 weeks
Measured: Week 0 - Week 48
PART A,B:Time to first asthma exacerbation/severe asthma exacerbation over 48 weeks
Measured: Week 0 - Week 48
PART A,B: Proportion of participants without any asthma exacerbations/severe asthma exacerbations over 48 weeks
Measured: 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
Measured: Week 0 - Week 48
PART A,B: Change from baseline in Asthma Control Questionnaire (ACQ-6) at Week 48
Measured: Week 0 - Week 48
PART A,B: Change from baseline in Asthma Quality of Life Questionnaire (Standardised) + 12 at Week 48
Measured: 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
Measured: Week 0 - Week 48
PART B: Change from baseline in Patient Global Impression of Change at Week 48
Measured: Week 0 - Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start24 Jul 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion23 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Windward Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omar Khwaja, MD, Study director, Windward Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120503
- Sponsor's protocol ID
- WB-2101
- Other IDs
- 2025-521391-58-00, U1111-1319-6369, 2025
- Acronym
- Polaris
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No