HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST TSLP for Asthma

Inclusion criteria

• {"criterion_text":"- 1. Age 18 through 75, inclusive at the time of signing the informed consent\n- 5. Asthma: Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 and post-BD reversibility of FEV1 ≥12% and ≥200 mL during Visit 1. Documented history of post-BD FEV1 reversibility or positive methacholine challenge in the past 24 months will be accepted in place of reversibility during screening.\n- 6. T2-High Phenotype: Elevated peripheral BEC of ≥150 cells/µL that is related to asthma at Visit 1. If a participant is believed to have a high likelihood of eosinophilic asthma but eosinophils are <150 cells/µL at Visit 1, eosinophils ≥150 cells/µL during the Runin period will be accepted. OR Documented history of BEC ≥300 cells/µL related to asthma in prior 12 months.\n- 7. Airflow limitation as indicated by pre-BD FEV1 value of ≥30% and ≤90%, predicted at Visit 1.\n- 8. Asthma Control: Participants must have an ACQ-6 score of ≥1.5 twice during Visit 1 and Screening Run-in visits. The first time must be at Visit 1. The second time must be at Visit 4 (Week 0).\n- 9. Participants must have received a physician-prescribed asthma controller maintenance regimen with low, medium-, or high-dose ICS (Global Initiative for Asthma [GINA] step 3 to 5). At least 1 additional maintenance asthma controller medication is required, according to standard of care (e.g., LABA, leukotriene modifier, 5-Lipoxygenase inhibitors, theophylline, LAMA, chromones and/or OCS). Inhaled corticosteroids can be contained within an ICS/LABA combination product. The use of ICS plus at least 1 additional asthma controller medication must have been documented for at least 3 months prior to Visit 1. Patients with mild asthma (GINA step 1 to 2) are not eligible. If on allergen-specific immunotherapy, participants must be on a stable maintenance dose and schedule for at least 2 months prior to Visit 1.\n- 15. Participants must have a history of at least 1 asthma exacerbation in the 12 months prior to Visit 1. An asthma exacerbation is defined as a worsening of asthma symptoms that leads to either of the following: •\tthe use of systemic corticosteroids or increase in maintenance dose of oral corticosteroids for at least 3 days (a single depot-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids), or •\tan emergency room (ER) visit due to asthma, or •\tan inpatient hospitalization due to asthma.\n- 10. Written informed consent and any locally required authorization obtained from the participant prior to performing any protocol-related procedures.\n- 11. Randomization Inclusion Criteria: Participants must demonstrate acceptable inhaler, peak flow meter, and spirometry techniques during the Screening Run-in period (from Visit 2 to Visit 4).\n- 12. Randomization Inclusion Criteria: Participants must demonstrate ≥70% compliance with usual asthma controller medications during the Screening Run-in period (from Visit 2 to Visit 4) based on the Asthma Symptom Diary.\n- 13. Randomization Inclusion Criteria: Participants must demonstrate ≥70% compliance with required use of the electronic patient-reported outcome (ePRO) device; 70% compliance is defined as completing the Asthma Symptom Diary for any 7 mornings and any 7 evenings in the last 10 days of the Screening Run-in period (Visit 2 to Visit 4).\n- 14. Randomization Inclusion Criteria: FeNO of ≥25 ppb\n- 2. Males or eligible females. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Is not a woman of childbearing potential (WOCBP) as defined in Appendix 11.4 OR 2. Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, 28 days prior to the first dose of the trial drug and during the trial intervention period until at least 36 weeks after the last administered dose. A WOCBP must have a negative serum pregnancy test at Screening and a highly sensitive pregnancy test (urine or serum) within 24 hours before each dose of trial drug. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials.\n- 3. Gamete Donation: Male participants should not donate nor cryopreserve sperm, and female participants should not donate nor cryopreserve ova for the duration of the trial from Visit 1 until the end of the safety Follow-up period (Week 60).\n- 4. Body mass index between 18 and 40 kg/m2 inclusive, and weight ≥40 kg at Visit 1."}

Exclusion criteria

• {"criterion_text":"- 1. Concurrent Respiratory Disease Participants with a known, pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current acute viral or bacterial infection (including COVID-19), diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma. An established diagnosis of occupational asthma, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, or allergic bronchopulmonary aspergillosis.\n- 18. Recent Medication Start: Start of leukotriene modifying agents (e.g., montelukast, zileuton), within less than 3 months prior to Visit 1, oral or ophthalmic β-adrenergic antagonists (e.g., propranolol), or recent oral corticosteroid burst (including taper) within 15 days prior to Visit 1 or during the Screening Run-in period.\n- 19. Smoking history Current smokers (tobacco and marijuana) or former smokers with a smoking history ≥10 pack years and participants using vaping products, including electronic cigarettes.\n- 2. Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 15 days prior to Visit 1.\n- 20. Alcohol/Substance abuse History of chronic alcohol or drug abuse within 24 months prior to Visit 1.\n- 21. Hypersensitivity History of sensitivity to any component of the investigational product formulation or a historyof drug or other allergy that, in the opinion of the Investigator or medical monitor contraindicates their participation. History of documented immune complex disease (Type III hypersensitivity reactions) or vasculitis following monoclonal antibody (mAb) administration\n- 22.Pregnancy and Gamete Donation Participants who are pregnant, lactating or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of trial participation. Participants should not plan to donate nor cryopreserve sperm or ova during the trial, from Visit 1 until the end of the safety follow up period (Week 60, Visit 15).\n- 23. Adherence Participants who have known evidence of lack of adherence to controller medications, inability to follow physician’s recommendations or unwillingness or inability to follow trial procedures and instructions through to Week 60 (Visit 15).\n- 24. Anticipated Procedures Planned surgical procedures requiring general anesthesia or in-patient stay for >1 day during the conduct of the trial.\n- 3. Eosinophilic Diseases Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.\n- 4. Parasitic Infections Participants with a helminth parasitic infection diagnosed within 24 weeks of Visit 1 that has not been treated or has not responded to standard of care therapy.\n- 10. Evidence of a clinically significant infection or receiving treatment with antibiotics or antiviral medications at Visit 4 (Week 0, Day 1).\n- 5. Tuberculosis Participants with active or latent tuberculosis (TB) or who have required treatment for TB within the 12 months prior to Visit 1. Note: If clinically indicated, additional testing for TB should be performed by the investigator during the screening/ Run-in period and ahead of the randomization visit. The choice to perform a screening test e.g., QuantiFERON Gold Plus test is per investigator’s judgment according to local licensing and standard of care.\n- 6. Immunodeficiency A known primary or acquired immunodeficiency (e.g., HIV) other than that explained by the use of corticosteroids taken as therapy for asthma. Asymptomatic selective immunoglobulin A or immunoglobin G subclass deficiency is permitted.\n- 7. Liver Disease Cirrhosis or current unstable liver or biliary disease per Investigator’s assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice or known hepatic or biliary abnormalities. NOTE: Stable non-cirrhotic chronic liver disease due to Gilbert's syndrome or asymptomatic gallstones are acceptable if the participant otherwise meets entry criteria.\n- 8. History of hepatitis B or C. Participants with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.\n- 9. Malignancy History of cancer other than participants who have had basal cell carcinoma provided that curative therapy was completed at least 12 months prior to Visit 1.\n- 25. Concurrent Clinical Trial Participation Concurrent enrollment in another clinical trial involving an investigational interventional treatment.\n- 26. Laboratory or Other Abnormalities Any clinically relevant abnormal findings in hematology, clinical chemistry, or urinalysis (laboratory results from Visit 1), which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the trial, or may influence the results of the trial, or the participant’s ability to participate in the trial.\n- 27. Liver Chemistry (laboratory results from Visit 1) • Alanine aminotransferase (ALT) >2x upper limit of normal (ULN) • Total bilirubin 1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%\n- 28. Electrocardiogram (ECG) Clinically significant abnormality on ECG that would impact the participant’s safety or participation during the trial, based on evaluation of the Investigator.\n- 29. Viral Serology • Positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody serology at Visit 1. • A positive HIV test at Screening.\n- 11. Cardiac Disease Recent history (i.e., 3 months or less prior to Visit 1) of myocardial infarction, arterial, or venous thromboembolism, stroke, transient ischemic event, unstable angina, any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the 3 months prior to Visit1, or participants who have been hospitalized for cardiac failure during the past year prior to Visit 1. Known valvulopathy or pulmonary hypertension\n- 30. Pregnancy A positive urine pregnancy test confirmed by serum pregnancy test at randomization.\n- 31. Unstable Asthma Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the Investigator considers the participant’s asthma is stable and at their baseline.\n- 32. Maintenance Asthma Therapy Any change in the dose or regimen of baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the Screening Run-in period.\n- 33. Intercurrent Respiratory Infections Any acute viral or bacterial upper or lower respiratory infection during the Screening Run-in period, or at Visit 4 (Week 0, Day 1).\n- 12. Vasculitis Current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at Visit 1 will be evaluated and current vasculitis must be excluded.\n- 13. Other Concurrent Medical Conditions Participants who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, or any other organ or system abnormalities that are uncontrolled with standard treatment or in the opinion of the Investigator and/or medical monitor may compromise the safety of the participant in the trial or interfere with evaluation of the investigational product or reduce the participant’s ability to participate in the trial. Participants with well-controlled comorbid disease (e.g., hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.\n- 14. Monoclonal antibodies targeting thymic stromal lymphopoietin: Participants who have received tezepelumab within 6 months of Visit 1 or who have a failure of anti-thymic stromal lymphopoietin (TSLP) therapy as assessed by the Investigator and documented as a failure to achieve a clinical meaningful improvement in asthma control, markers of airway inflammation, lung function, exacerbations, use of systemic corticosteroids, or symptoms despite adequate exposure (minimum of 12 consecutive weeks tezepelumab at the clinically approved dose, or at least 3 administrations of any other investigational anti-TSLP therapy).\n- 15. Other monoclonal antibodies, immunoglobulins, blood products or vaccines: • Receipt of any marketed biologic agent within 4 months or 5 half-lives prior to Visit 1, whichever is longer. • Receipt of immunoglobulin or blood products within 30 days prior to Visit 1 or during the Screening Run-in period. • Receipt of any live or attenuated vaccines within 15 days prior to Visit 1.\n- 16. Immunosuppressive Medications Use of immunosuppressive medication (e.g., methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular (IM) long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to Visit 1 or during the Screening Run-in period. Chronic oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma is permitted.\n- 17. Investigational Medications and Vaccines • Participants who have received treatment with any investigational nonbiologic agent within 30 days or 5 half-lives prior to Visit 1, whichever is longer. • Participants who have received treatment with an investigational biologic agent within 4 months or 5 half-lives prior to Visit 1, whichever is longer. • Receipt of experimental vaccinations within 30 days prior to randomization and up until the end of the trial."}

Primary endpoints

• {"endpoint_text":"- 1. Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), vital signs, laboratory assessments, and electrocardiogram (ECG) during the trial (Week 0 [Day 1] to Week 60).","definition_or_measurement_approach":"Safety assessments recorded from Week 0 (Day 1) through Week 60 including collection and reporting of TEAEs and TESAEs, regular vital signs, laboratory tests and ECGs per schedule of assessments."}
• {"endpoint_text":"- 2. WIN378 PK and anti-drug antibodies (ADA) during the trial (Week 0 [Day 1] to Week 60).","definition_or_measurement_approach":"Population pharmacokinetic sampling (13 samples per participant over period up to 60 weeks after first dose) and ADA assessments (8 samples per participant) collected according to protocol schedule to characterize PK and immunogenicity."}

Secondary endpoints

• {"endpoint_text":"- 1. Change from baseline in FeNO at week 24","definition_or_measurement_approach":"Change from baseline in fractional exhaled nitric oxide measured at Week 24 according to protocol FeNO assessments."}
• {"endpoint_text":"- 2. Change from baseline in FEV1 at Week 24 and Week 48","definition_or_measurement_approach":"Change from baseline in forced expiratory volume in 1 second (FEV1) measured pre- and post-bronchodilator at Weeks 24 and 48 using spirometry per schedule of assessments."}
• {"endpoint_text":"- 3. Change from baseline in FeNO at Week 24 and Week 48","definition_or_measurement_approach":"Change from baseline in FeNO measured at Weeks 24 and 48 according to protocol-specified FeNO procedures."}
• {"endpoint_text":"- 4. Change from baseline in BEC at Week 24 and Week 48","definition_or_measurement_approach":"Change from baseline in blood eosinophil counts measured at Weeks 24 and 48 using standard hematology assays."}
• {"endpoint_text":"- 5. An exposure-response analysis will be done to support selection of the optimal dose(s) for future testing. The analysis will describe the exposure-response relationship between concentration of WIN378 and change in FeNO, FEV1, and eosinophil count over 48 weeks.","definition_or_measurement_approach":"Exposure-response analysis relating WIN378 concentrations (PK) to pharmacodynamic and efficacy measures (FeNO, FEV1, eosinophil counts) over 48 weeks."}
• {"endpoint_text":"- 6. Change from baseline in lung function as measured by pre-bronchodilator (BD) and post-BD FEV1 and forced vital capacity (FVC) at Week 24 and Week 48","definition_or_measurement_approach":"Change from baseline in pre- and post-BD FEV1 and FVC measured by spirometry at Weeks 24 and 48."}
• {"endpoint_text":"- 7a. 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, and other measures of asthma control as measured by the Asthma Control Questionnaire (ACQ-6) at Week 48 in the overall population.","definition_or_measurement_approach":"Patient-reported outcomes collected via the Asthma Symptom Diary (ePRO) and ACQ-6 at Week 48 to assess symptom frequency/severity, activity limitation, rescue medication use and asthma control."}
• {"endpoint_text":"- 7b. Annualized asthma exacerbation rate (AAER), annualized rate of severe asthma exacerbations, time to first asthma exacerbation/severe asthma exacerbation, and proportion of participants with 1 or more asthma exacerbations/severe asthma exacerbations over 48 weeks","definition_or_measurement_approach":"Clinical event-based endpoints recorded during 48-week treatment period: exacerbations defined per protocol (systemic corticosteroid use, ER visit, or hospitalization). Analyses include AAER, time-to-event and proportions."}
• {"endpoint_text":"- 7c. Change from baseline in Asthma Quality of Life Questionnaire (Standardised) (AQLQ[S]+12) and European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48","definition_or_measurement_approach":"Patient-reported quality-of-life measures (AQLQ[S]+12 and EQ-5D-5L) collected at Week 48 per schedule."}

Methods

• Germany: Social media advertisements (including Facebook posts), recruitment flyers, SMS templates, ICF flipchart, FeNO explained flipchart, participant booklet and patient card (documents K2_WB-2101_Social-media-Advertisement-EU_DEU_deu_Public; K2_WB-2101_Facebook-Post-EU_DEU_deu_Public; K2_WB-2101_Recruitment-Flyer-EU_DEU_deu_Public; K2_WB-2101_SMS-Template_DEU_deu_Public; K2_WB-2101_ICF-Flipchart_DEU_deu_Public; K2_WB-2101_Participant-Booklet_DEU_deu_Public).
• Spain: Social media advertisement (Facebook), recruitment flyer, SMS template, participant booklet, FeNO flipchart, ICF flipchart and other patient materials (documents K2_WB-2101_Facebook-Post-EU_ESP_SPA_Public; K2_WB-2101_Recruitment-Flyer-EU_ESP_SPA_Public; K2_WB-2101_Asthma-Study-SMS-Template_ESP_SPA_Public; K2_WB-2101_Participant-Booklet_ESP_SPA_Public; K2_WB-2101_FeNO-Explained-FlipChart_ESP_SPA_Public).
• Sweden: Social media advertisement, Facebook post, recruitment flyer, SMS template, participant booklet, FeNO flipchart, ICF flipchart and advertisement materials (documents K2_WB-2101_Social-media-Advertisement_SWE_swe_Public; K2_WB-2101_Facebook-Post_SWE_swe_Public; K2_WB-2101_Recruitment-Flyer_SWE_swe_Public; K2_WB-2101_AsthmaStudy-SMS-Template_SWE_swe_Public; K2_WB-2101_Participant-Booklet_SWE_swe_Public).
• Bulgaria: Country-specific recruitment arrangements and ICF materials (K1_WB-2101_Recruitment Arrangements_BGR_BG_Public; L1_WB-2101_Main ICF_BGR_BG_Public).
• France: Recruitment arrangements and patient information materials including patient card and ICF (K1_WB-2101_Recruitment-Arrangements_FRA_French_Public; L2_WB-2101_Patient-Card_FRA_French_Public; L1_WB-2101_Main ICF_FRA_French_Public).

Bulgaria

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

11-11-2025

Processing Time Days

34

Number Of Sites

6

Number Of Participants

19

France

Earliest CTIS Part Ii Submission Date

22-09-2025

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

51

Number Of Sites

5

Number Of Participants

15

Germany

Earliest CTIS Part Ii Submission Date

23-10-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

127

Number Of Sites

11

Number Of Participants

81

Spain

Earliest CTIS Part Ii Submission Date

10-10-2025

Latest Decision Or Authorization Date

05-03-2026

Processing Time Days

146

Number Of Sites

9

Number Of Participants

16

Sweden

Earliest CTIS Part Ii Submission Date

10-10-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

150

Number Of Sites

4

Number Of Participants

22

Primary sponsor

Full Name

Windward Bio AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

PPD Development LP

Responsibilities

Multiple study operational functions (sponsorDuties codes: 1,11,12,13,2,3,4,5,6,8) as listed in CTIS third-party roles

Name

PPD Global Central Labs

Responsibilities

Clinical haematology, Clinical chemistry, Anti-drug antibodies (ADA), Pharmacokinetics (PK), Biomarker Assessment

Name

Suvoda LLC

Responsibilities

Treatment Randomisation; other duties (codes include 3)

Name

Medidata Solutions Inc.

Responsibilities

Data/eClinical platform responsibilities (code 7)

Third parties

• {"country":"United States","full_name":"Allucent (US) LLC","duties_or_roles":"Codes: 11; 15 (US FDA (IND) Submission)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"15 (Treatment Randomisation); 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"15 (eCOA)","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Swiss BioQuant AG","duties_or_roles":"15 (Analytical Chemistry, Bioanalytical Lab); 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Codes: 1, 11, 12, 13, 2, 3, 4, 5, 6, 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Meeting Protocol Worldwide LP","duties_or_roles":"15 (Patient Services - Travel/Reimbursement)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"CIMS Global LLC","duties_or_roles":"10, 15 (Programming)","organisation_type":"Industry"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"15 (Clinical haematology, Clinical chemistry, Anti-drug antibodies (ADA), Pharmacokinetics (PK), Biomarker Assessment); 4","organisation_type":"Pharmaceutical company"}