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.

2025-521391-58-00 Protocol WB-2101 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 28 Nov 2025 · Status Ongoing, recruiting · 5 EU/EEA countries · 35 sites · Protocol WB-2101

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 211
Countries 5
Sites 35

Asthma

To evaluate the safety and tolerability of WIN378. To describe the pharmacokinetics (PK) and immunogenicity of WIN378.

Key facts

Sponsor
Windward Bio AG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
28 Nov 2025 → ongoing
Decision date (initial)
2025-11-11
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Windward Bio AG

External identifiers

EU CT number
2025-521391-58-00
WHO UTN
U1111-1319-6369

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Dose response, Safety, Others, Therapy, Efficacy

To evaluate the safety and tolerability of WIN378.
To describe the pharmacokinetics (PK) and immunogenicity of WIN378.

Secondary objectives 7

  1. To evaluate the dose-response of WIN378 on fractional exhaled nitric oxide (FeNO) at 24 weeks in adult participants with moderate or severe asthma.
  2. To evaluate the effect of 3 dose levels of WIN378 on forced expiratory volume in 1 second (FEV1) at 24 and 48 weeks in adult participants with moderate or severe asthma.
  3. To evaluate the effect of 3 dose levels of WIN378 on FeNO at 24 and 48 weeks in adult participants with moderate or severe asthma
  4. To evaluate the effect of 3 dose levels of WIN378 on blood eosinophil counts (BEC) at 24 and 48 weeks in adult participants with moderate or severe asthma.
  5. To describe the exposure-response relationship of WIN378 to inform dose selection for future studies
  6. To evaluate the effect of 3 dose levels of WIN378 on lung function at 24 and 48 weeks in adult participants with moderate or severe asthma
  7. To evaluate the effect of WIN378 on asthma symptoms and metrics related to asthma control.

Conditions and MedDRA coding

Asthma

VersionLevelCodeTermSystem organ class
20.0 PT 10003553 Asthma 100000004855

Study design 4 periods

#TitleAllocationBlindingRoles blindedArms
1 Screening Period
The pre-treatment period (Week −8 to 0) consists of the Screening, and Screening Run-in periods (discussed in Section 5.1.2). The Screening period includes Visit 0 and Visit 1 (Weeks −8 to −5). This period will last up to 4 weeks, but may be reduced if results from the assessments are available earlier or may be prolonged if participants experience an asthma exacerbation or respiratory infection requiring additional treatment such as change in OCS. During this period, participants will be provided with informed consent and screened for inclusion and exclusion criteria. At Visit 0, participants will complete the informed consent form and the site staff should inform the participants about preparation for the screening spirometry visit and all subsequent visits. At Visit 1, participants will receive and be instructed on how to use an Asthma Symptom Diary on the electronic patient-reported outcome (ePRO) device. The Asthma Symptom Diary will be used to assess changes from baseline in asthma symptoms, including daytime and nighttime symptom frequency and severity, activity avoidance and limitation, asthma-related stress and fatigue, and asthma medication use. It will also be used to assess participant compliance with use of asthma controller maintenance treatment, e.g., ICS/LABA, and of the ePRO device. Participants will be instructed on correct use of their controller medication, rescue inhaler use, peak flow meter, and spirometry methods and must demonstrate acceptable techniques. During this period, participants will complete the ACQ-6. Participants must have an ACQ-6 score of ≥1.5. Participants may be rescheduled for administrative reasons (technical problem) or if not meeting certain eligibility criteria, e.g., post-BD reversibility (see Schedule of Assessments [Schedule of Assessments]). If participants finally do not pass the Eligibility Assessment, they will be considered a screen failure and may be rescreened with a new participant screening ID. Rescreening is generally only permitted once, when there is a reasonable expectation that the participant will become eligible for the trial. Participants failing the ACQ-6 score must not be rescreened. If participants pass the Eligibility Assessment and all inclusion and exclusion criteria defined for the screening phase, participants will move forward to the Screening Run-in Period.
 Not Applicable None
2 Screening Run-In Period
After participants meet the requirements of the Screening period as described in Section 5.1.1, they will move forward to the Screening Run-in Period. The Screening Run-in period begins at Week −4, and it continues through Week 0. Visit 2 will occur at Week −4, Visit 3 will occur at Week −2, and Visit 4 will occur at the end of the Screening Run-in period at Week 0. Each visit window can be scheduled up to ±3 days from the planned visit schedule. Visit 3 (Week −2) is not an on-site visit, these assessments are done remotely through a telephone call to the participant to ask about any AEs, changes in concomitant medications, and site will conduct a remote check of the participants compliance in completing the eDiary as required. Throughout the Screening Run-in period, the Asthma Symptom Diary will be reviewed, and it must show ≥70% participant compliance with use of ICS and asthma controller medication. The Asthma Symptom Diary must also show ≥70% compliance with required use of the ePRO device (e.g. morning and evening daily diary entries). At these visits, participants must also show acceptable inhaler, peak flow meter, and spirometry techniques. Participants will complete the ACQ-6 during trial visits at the site on the ePRO device provided for home assessments and must have a score of ≥1.5 at Week 0 (Visit 4). Participants must also have a FeNO ≥25 ppb at Week 0 (Visit 4) in order to be randomized. If FeNO <25 ppb, participants may be rescheduled once to repeat FeNO testing only and be subsequently randomized if they meet the threshold. If participants pass all assessments and all inclusion and exclusion criteria, they will move forward to the Treatment Period. Participants will have the opportunity to extend the Screening Run-in period by another 2 weeks. Exceptions to allow extension of the Screening Run-in period include for example if the ePRO malfunctions, or if the participant did not understand the requirements for ePRO completion and needed retraining, or if the participant experienced an exacerbation or worsening that needed treatment with OCS or increases in dose of ICS. If a participant has an asthma exacerbation requiring treatment (i.e. additional or increase in systemic steroids) they may delay their randomization visit so the Investigator can ensure they have returned to their asthma baseline for at least 7 days. In this setting the participant may be allowed to extend their Screening Run-in period from 4 to 6 weeks. If the participant has not returned to their asthma baseline by the end of 6 weeks, they should not proceed to randomization but will be allowed to be rescreened once they are back at baseline and are stable. In a situation where, at the 4-week timepoint the Screening Run-in period is extended to 6 weeks, the participant should undergo an unscheduled in person or telephone visit that is equivalent to Visit 3 (Week −2).
 Not Applicable None
3 Treatment Period
At Visit 4 (Baseline), participants will be randomized into 1 of 4 treatment groups in an overall randomization ratio of 3:1:1:3 to 600, 300, and 150 mg WIN378, or placebo. Doses of 150, 300, and 600 mg WIN378 or placebo will be administered subcutaneously in the abdomen or top of the thighs by two 2 mL injections every 24 weeks by a qualified trial staff member. A sham injection consisting of placebo will be used to mask doses that only require a single injection of WIN378 (Table 1). The treatment period lasts 48 weeks, starting with Visit 4 (Baseline) at Day 1 and continuing through Visit 14 at Week 48. There will be 2 dose administrations per participant, the first at Week 0 (Visit 4) and the second at Week 24 (Visit 10). Blood samples will be collected pre-dose, up to 60 weeks after first dose, and up to 36 weeks after second dose administrations (13 samples per participant) to characterize the population PK of WIN378 and to quantify the impact of participant covariates such as weight, race, and sex. Exposure-response (safety and efficacy) analysis will be performed as appropriate. Samples for ADA assessments (8 samples per participant) will be collected over the 24-week dosing interval for each dose administration and at Follow-up. At each visit, the Asthma Symptom Diary will be reviewed, including daytime and nighttime symptom frequency and severity, activity avoidance and limitation, asthma-related stress and fatigue, and rescue asthma medication use. Asthma management will also be measured using the ACQ-6 and the AQLQ(S)+12. At every visit, participants will also be asked about any AEs they may have experienced. Assessments at each visit should be performed in the order shown in the Schedule of Assessments.
 Randomised Controlled Double [{"id":169440,"code":4,"name":"Analyst"},{"id":169436,"code":5,"name":"Carer"},{"id":169437,"code":3,"name":"Monitor"},{"id":169438,"code":2,"name":"Investigator"},{"id":169439,"code":1,"name":"Subject"}] Placebo: Subcutaneous administration of 2 x 2 mL placebo injections every 24 weeks
WI378 (300mg): Subcutaneous administration of 1 x 2 mL, 150mg/mL injection AND 1 x 2 mL placebo injection every 24 weeks.
WIN378 (150mg): Subcutaneous administration of 1 x 2 mL, 75mg/mL injection AND 1 x 2 mL placebo injection every 24 weeks.
WIN378 (600mg): Subcutaneous administration of 2 x 2 mL, 150mg/mL injections after 24 weeks.
4 Post-Treatment Follow-Up Period
A follow-up visit (Visit 15) will occur 12 weeks after the end of the treatment period at Week 60. Participants will complete the ACQ-6, AQLQ(S)+12, and EQ-5D-5L; complete a physical examination and blood draw; and report any AEs.
 Not Applicable None

Regulatory references

Scientific advice from competent authorities
European Medicines Agency, Food And Drug Administration
Plan to share IPD
Yes
IPD plan description
Individual treatment assignments and data will be shared, upon request, after the study is complete

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

  1. 1. Age 18 through 75, inclusive at the time of signing the informed consent
  2. 10. Written informed consent and any locally required authorization obtained from the participant prior to performing any protocol-related procedures.
  3. 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).
  4. 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.
  5. 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).
  6. 14. Randomization Inclusion Criteria: FeNO of ≥25 ppb
  7. 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.
  8. 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).
  9. 4. Body mass index between 18 and 40 kg/m2 inclusive, and weight ≥40 kg at Visit 1.
  10. 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.
  11. 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.
  12. 7. Airflow limitation as indicated by pre-BD FEV1 value of ≥30% and ≤90%, predicted at Visit 1.
  13. 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).
  14. 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.
  15. 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: • the 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 • an emergency room (ER) visit due to asthma, or • an inpatient hospitalization due to asthma.

Exclusion criteria 33

  1. 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.
  2. 10. Evidence of a clinically significant infection or receiving treatment with antibiotics or antiviral medications at Visit 4 (Week 0, Day 1).
  3. 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
  4. 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.
  5. 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.
  6. 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).
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 2. Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 15 days prior to Visit 1.
  13. 20. Alcohol/Substance abuse History of chronic alcohol or drug abuse within 24 months prior to Visit 1.
  14. 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
  15. 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).
  16. 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).
  17. 24. Anticipated Procedures Planned surgical procedures requiring general anesthesia or in-patient stay for >1 day during the conduct of the trial.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 8. History of hepatitis B or C. Participants with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.
  24. 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.
  25. 25. Concurrent Clinical Trial Participation Concurrent enrollment in another clinical trial involving an investigational interventional treatment.
  26. 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.
  27. 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%
  28. 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.
  29. 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.
  30. 30. Pregnancy A positive urine pregnancy test confirmed by serum pregnancy test at randomization.
  31. 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.
  32. 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.
  33. 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. 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).
  2. 2. WIN378 PK and anti-drug antibodies (ADA) during the trial (Week 0 [Day 1] to Week 60).

Secondary endpoints 9

  1. 1. Change from baseline in FeNO at week 24
  2. 2. Change from baseline in FEV1 at Week 24 and Week 48
  3. 3. Change from baseline in FeNO at Week 24 and Week 48
  4. 4. Change from baseline in BEC at Week 24 and Week 48
  5. 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.
  6. 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
  7. 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.
  8. 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
  9. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

WIN378

PRD12653942 · Product

Active substance
Human IGG1 Monoclonal Antibody Against Tslp
Substance synonyms
HBM9378, SKB378, WIN378
Pharmaceutical form
INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
300 mg milligram(s)
Max total dose
600 mg milligram(s)
Max treatment duration
48 Week(s)
Authorisation status
Not Authorised
MA holder
WINDWARD BIO AG
Paediatric formulation
No
Orphan designation
No

Placebo 1

Matching placebo for WIN378

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Windward Bio AG

Sponsor organisation
Windward Bio AG
Address
Steinentorstrasse 23
City
Basel
Postcode
4051
Country
Switzerland

Scientific contact point

Organisation
Windward Bio AG
Contact name
Mahir Karababa

Public contact point

Organisation
Windward Bio AG
Contact name
Mahir Karababa

Third parties 9

OrganisationCity, countryDuties
Allucent (US) LLC
ORG-100049428
 Cary, United States Code 11, Other
Suvoda LLC
ORG-100043523
 Conshohocken, United States Other, Interactive response technologies (IRT)
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Other
Swiss BioQuant AG
ORG-100037230
 Reinach Bl, Switzerland Other, Laboratory analysis
PPD Development LP
ORG-100011560
 Wilmington, United States On site monitoring, Code 11, Code 12, Code 13, Code 2, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, Code 8
Meeting Protocol Worldwide LP
ORG-100049471
 Dallas, United States Other
CIMS Global LLC
ORL-000015175
 Somerset, United States Code 10, Other
PPD Global Central Labs
ORG-100046496
 Zaventem, Belgium Other, Laboratory analysis

Locations

5 EU/EEA countries · 35 investigational sites

By country

CountryMS statusPlanned subjectsSites
Bulgaria Ongoing, recruiting 19 6
France Ongoing, recruitment ended 15 5
Germany Ongoing, recruiting 81 11
Spain Ongoing, recruiting 16 9
Sweden Ended 22 4
Rest of world
Argentina, Australia, United States, United Kingdom, Peru
 — 58 —

Investigational sites

Bulgaria

6 sites · Ongoing, recruiting
Medical Center New Rehabilitation Center EOOD
n/a, Bulevard Tsar Simeon Veliki 158, 6001, Stara Zagora
Medical Center Prolet EOOD
N/A, Ulitsa Olimpi Panov 25, 7000, Ruse
Diagnostics And Consultation Center Convex Ltd.
N/A, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Medical Centre Pratia Clinic EOOD
N/A, Ulitsa Doktor Siyko Siev 27, 5500, Lovech
Medical Center Excelsior OOD
n/a, Lozenets, Ulitsa Golo Birdo 4, Sofiya
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department of Pneumology and Phthisiatrics, Bulevard Gen. Stoletov No 67a, 1233, Sofia

France

5 sites · Ongoing, recruitment ended
Centre Hospitalier Universitaire Grenoble Alpes
N/A, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Dijon
Pulmonology and respiratory intensive Care department, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Bordeaux
Hopital Haut-Lévêque Centre d’investigation clinique-Unité Pneumologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nantes
Service de Pneumologie-Institut du Thorax, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Montpellier
Département de maladies respiratoires, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier

Germany

11 sites · Ongoing, recruiting
Velocity Clinical Research Germany GmbH
n/a, Sandstrasse 18, Innenstadt, Luebeck
POIS Sachsen GmbH
n/a, Foepplstrasse 5, Schoenefeld-Abtnaundorf, Leipzig
Studienzentrum Dr. Claus Keller
n/a, Usinger Str. 5, 60389, Frankfurt am Main
Praxis Dr.med. Jan Feimer
n/a, Odeonsplatz 2, 80539, München
KPPK GmbH
n/a, Hauptstrasse 175, 56170, Bendorf
Pneumo Studien Darmstadt GmbH
n/a, Grafenstrasse 13, 64283, Darmstadt
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
n/a, Torstrasse 117, Mitte, Berlin
Pneumologisches Studienzentrum München-West
n/a, Gleichmannstr. 5, 81241, München
IKF Pneumologie GmbH & Co. KG
n/a, 2nd Floor, Schaumainkai 101-103, Frankfurt Am Main
IKF Pneumologie GmbH & Co. KG
n/a, Haifa-Allee 24, Bretzenheim, Mainz
Universitaetsklinikum Essen AöR
Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Tueschener Weg 40, Hufelandstrasse 55, Holsterhausen, Essen

Spain

9 sites · Ongoing, recruiting
Hospital Universitario Donostia
Neumología, Pasealeku Doct. Begiristain 109, 20014, Donostia
Futuremeds Spain S.L.
Neumología, Glorieta De Mejico 1, 41012, Sevilla
Hospital Vithas Xanit Internacional
Neumología, Avenida De Los Argonautas S/N, 29639, Benalmadena
Hospital Universitario Quironsalud Madrid
Neumologia, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Virgen De La Victoria
Neumología, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Futuremeds Spain S.L.
Internal medicine, Avenida Octavio Augusto S/n, 11139, Chiclana De La Frontera
Futuremeds Spain S.L.
Neumologia, Calle De La Granja 8, 28003, Madrid
Hospital Universitario Hm Sanchinarro
Neumología, Calle Ona 10, 28050, Madrid
Futuremeds Spain S.L.
Neumologia, Calle De La Granja 8, 28003, Madrid

Sweden

4 sites · Ended
Cordinator Medical Service AB
N/A, Brigadgatan 26, 587 58, Linkoping
MediTrials AB
N/A, Per Albin Hanssons Vag 41, Fosie, Malmo
Halsoklustret AB
N/A, Sankt Eriksgatan 30, Vastermalm, Stockholm
Region Skane Skanes Universitetssjukhus
N/A, Entregatan 7, 222 42, Lund

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Bulgaria 2025-12-03 2025-12-03
France 2026-01-19 2026-01-19 2026-03-27
Germany 2025-11-28 2025-11-28
Spain 2025-12-02 2025-12-02
Sweden 2025-12-17 2025-12-17 2026-03-27

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 79 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Windward Bio_WB-2101_Protocol_2025-521391-58-00_Public 1.1
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification letter 5_2025-521391-58-00_Public n/a
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification letter 6_2025-521391-58-00_Public n/a
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification letter_2025_521391-58-00_Public n/a
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification Letter_2025-521391-58-00_1_Public n/a
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification Letter_2025-521391-58-00_2_Public n/a
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification Letter_2025-521391-58-00_3_Public n/a
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification Letter_2025-521391-58-00_4_Public n/a
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification Letter_2025-521391-58-00_Public n/a
Protocol (for publication) D2_Windward Bio_WB-2101_Protocol clarification letter_2025-521391-58-00_Public n/a
Protocol (for publication) D4_Windward Bio_WB-2101_Diary1_BGR_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary1_DEU_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary1_ESP_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary1_FRA_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary1_SWE_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary2_BGR_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary2_DEU_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary2_ESP_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary2_FRA_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Diary2_SWE_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Patient Card_DEU_Public 2.1
Protocol (for publication) D4_Windward Bio_WB-2101_Patient Card_ESP_Public 2.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire1_BGR_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire1_DEU_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire1_ESP_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire1_FRA_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire1_SWE_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire2_BGR_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire2_DEU_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire2_ESP_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire2_FRA_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire2_SWE_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire3_BGR_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire3_DEU_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire3_ESP_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire3_FRA_Public 1.0
Protocol (for publication) D4_Windward Bio_WB-2101_Questionnaire3_SWE_Public 1.1
Recruitment arrangements (for publication) K1_WB-2101_Recruitment Arrangements_BGR_BG_Public 1.0
Recruitment arrangements (for publication) K1_WB-2101_Recruitment-Arrangements_ES 2
Recruitment arrangements (for publication) K1_WB-2101_Recruitment-Arrangements_FRA_French_Public 1.0
Recruitment arrangements (for publication) K1_WB-2101_Recruitment-arrangements_SE_Swedish_Public N/A
Recruitment arrangements (for publication) K1-WB-2101_Recruitment-and-Informed-Consent-Procedure_DE 2.0
Recruitment arrangements (for publication) K2_WB-2101_Advertisement_SE_SWE_Public n/a
Recruitment arrangements (for publication) K2_WB-2101_Asthma-Study-SMS-Template_ESP_SPA_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_AsthmaStudy-SMS-Template_SWE_swe_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Facebook-Post_SWE_swe_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Facebook-Post-EU_DEU_deu_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Facebook-Post-EU_ESP_SPA_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_FeNO-Explained-FlipChart_DEU_deu_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_FeNO-Explained-FlipChart_ESP_SPA_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_FeNO-Explained-FlipChart_SWE_swe_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_ICF-Flipchart_DEU_deu_Public 1.1
Recruitment arrangements (for publication) K2_WB-2101_ICF-Flipchart_SWE_swe_Public 1.1
Recruitment arrangements (for publication) K2_WB-2101_Participant-Booklet_DEU_deu_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Participant-Booklet_ESP_SPA_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Participant-Booklet_SWE_swe_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_POLARIS-ICF-Flipchart_ESP_SPA_Public 1.1
Recruitment arrangements (for publication) K2_WB-2101_Recruitment-Flyer_SWE_swe_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Recruitment-Flyer-EU_DEU_deu_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Recruitment-Flyer-EU_ESP_SPA_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_SMS-Template_DEU_deu_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Social-media-Advertisement_SWE_swe_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Social-media-Advertisement-EU_DEU_deu_Public 1.0
Recruitment arrangements (for publication) K2_WB-2101_Social-media-Advertisement-EU_ESP_SPA_Public 1.0
Subject information and informed consent form (for publication) L1_WB-2101_Future-Research-ICF_DE_German_Public 1.0
Subject information and informed consent form (for publication) L1_WB-2101_Main ICF_BGR_BG_Public 1.0
Subject information and informed consent form (for publication) L1_WB-2101_Main ICF_BGR_EN_Public 1.0
Subject information and informed consent form (for publication) L1_WB-2101_Main ICF_FRA_French_Public 1.0
Subject information and informed consent form (for publication) L1_WB-2101_Main ICF_SE_Swedish_Public 1.0
Subject information and informed consent form (for publication) L1_WB-2101_Main-ICF_DE_German_Public 1.0
Subject information and informed consent form (for publication) L1_WB-2101_Main-ICF_ES_Spanish_Public 1.0
Subject information and informed consent form (for publication) L2_WB-2101_Patient-Card_FRA_French_Public 2.0.0
Synopsis of the protocol (for publication) D1_Windward Bio_WB-2101_PLPS_2025-521391-58-00_BGR_Public 1.1
Synopsis of the protocol (for publication) D1_Windward Bio_WB-2101_PLPS_2025-521391-58-00_DEU_Public 1.1
Synopsis of the protocol (for publication) D1_Windward Bio_WB-2101_PLPS_2025-521391-58-00_ENG_Public 1.1
Synopsis of the protocol (for publication) D1_Windward Bio_WB-2101_PLPS_2025-521391-58-00_ESP_Public 1.1
Synopsis of the protocol (for publication) D1_Windward Bio_WB-2101_PLPS_2025-521391-58-00_FRA_Public 1.1
Synopsis of the protocol (for publication) D1_Windward Bio_WB-2101_PLPS_2025-521391-58-00_SWE_Public 1.1
Synopsis of the protocol (for publication) D1_Windward Bio_WB-2101_Protocol synopsis_2025-521391-58-00_BGR_Public 1.1

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-07-16 Sweden Acceptable
2025-11-07
 2025-11-10
2 NON SUBSTANTIAL MODIFICATION NSM-1 2026-01-09 Sweden Acceptable
2025-11-07
 2026-01-09
3 NON SUBSTANTIAL MODIFICATION NSM-2 2026-01-15 Sweden Acceptable
2025-11-07
 2026-01-15
4 SUBSTANTIAL MODIFICATION SM-2 2026-01-20 Acceptable 2026-02-27
5 SUBSTANTIAL MODIFICATION SM-3 2026-01-23 Acceptable 2026-03-05
6 SUBSTANTIAL MODIFICATION SM-4 2026-02-04 Sweden Acceptable 2026-03-09

Related clinical trials