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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07120503




Registration number
Help: Registration number
NCT07120503
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
25/07/2025
Date registered
Help: Date registered
13/08/2025
Date last updated
Help: Date last updated
21/10/2026

Titles & IDs
Public title
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Scientific 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
Additional trial identifiers [1] 0 0
2025-521391-58-00
Additional trial identifiers [2] 0 0
WB-2101
Universal Trial Number (UTN)
Trial acronym
Polaris
Related trial records

Health condition
Health condition(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - WIN378
Treatment: Drugs - Placebo

Experimental: WIN378 - WIN378 SC injections

Experimental: Placebo - Placebo SC Injections


Treatment: Drugs: WIN378
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.

Treatment: Drugs: Placebo
A sham injection consisting of placebo to mask WIN378.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
PART A: Number of participants with treatment-emergent adverse events (TEAEs) during the study
Timepoint [1] 0 0
Week 0 - Week 60
Primary outcome [2] 0 0
PART A: Number of participants with treatment-emergent serious adverse events (TESAEs) during the study
Timepoint [2] 0 0
Week 0 - Week 60
Primary outcome [3] 0 0
PART A: Number of participants with abnormal vital signs during the study
Timepoint [3] 0 0
Week 0 - Week 60
Primary outcome [4] 0 0
PART A: Number of participants with abnormal laboratory assessments during the study
Timepoint [4] 0 0
Week 0 - Week 60
Primary outcome [5] 0 0
PART A: Number of participants with Clinically significant abnormal ECG results during the study
Timepoint [5] 0 0
Week 0 - Week 60
Primary outcome [6] 0 0
PART A: WIN 378 Pharmacokinetics: concentration at trough [Ctrough]
Timepoint [6] 0 0
Week 0 - Week 60
Primary outcome [7] 0 0
PART A: WIN 378 Pharmacokinetics: area under the concentration time curve [AUC]
Timepoint [7] 0 0
Week 0 - Week 60
Primary outcome [8] 0 0
PART A: WIN 378 Pharmacokinetics: maximum observed concentration [Cmax])
Timepoint [8] 0 0
Week 0 - Week 60
Primary outcome [9] 0 0
PART A: Number of participants with positive anti-drug antibodies (ADA) during the study
Timepoint [9] 0 0
Week 0 - Week 60
Primary outcome [10] 0 0
PART B: Annualized Asthma Exacerbation Rate (AAER)
Timepoint [10] 0 0
24 Weeks after last dose
Secondary outcome [1] 0 0
PART A,B: Change from baseline in FeNO at Week 24 and Week 48
Timepoint [1] 0 0
Week 0 - Week 24, Week 48
Secondary outcome [2] 0 0
PART A,B: Change from Baseline in Blood eosinophil count at Week 24 and Week 48
Timepoint [2] 0 0
Week 0 - Week 24, Week 48
Secondary outcome [3] 0 0
PART A,B: Change in pre-BD and post-BD FEV1 at Week 24 and Week 48
Timepoint [3] 0 0
Week 0 - Week 24, Week 48
Secondary outcome [4] 0 0
PART A: Change in pre-BD and post-BD forced vital capacity (FVC) at Week 24 and Week 48
Timepoint [4] 0 0
Week 0 - Week 24, Week 48
Secondary outcome [5] 0 0
PART A Annualized asthma exacerbation rate (AAER) over 48 weeks
Timepoint [5] 0 0
Week 0 - Week 48
Secondary outcome [6] 0 0
PART A Annualized rate of severe asthma exacerbations over 48 weeks
Timepoint [6] 0 0
Week 0 - Week 48
Secondary outcome [7] 0 0
PART A,B:Time to first asthma exacerbation/severe asthma exacerbation over 48 weeks
Timepoint [7] 0 0
Week 0 - Week 48
Secondary outcome [8] 0 0
PART A,B: Proportion of participants without any asthma exacerbations/severe asthma exacerbations over 48 weeks
Timepoint [8] 0 0
Week 0 - Week 48
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Week 0 - Week 48
Secondary outcome [10] 0 0
PART A,B: Change from baseline in Asthma Control Questionnaire (ACQ-6) at Week 48
Timepoint [10] 0 0
Week 0 - Week 48
Secondary outcome [11] 0 0
PART A,B: Change from baseline in Asthma Quality of Life Questionnaire (Standardised) + 12 at Week 48
Timepoint [11] 0 0
Week 0 - Week 48
Secondary outcome [12] 0 0
PART A,B: Change from baseline in European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48
Timepoint [12] 0 0
Week 0 - Week 48
Secondary outcome [13] 0 0
PART B: Change from baseline in Patient Global Impression of Change at Week 48
Timepoint [13] 0 0
Week 0 - Week 48

Eligibility
Key inclusion criteria
* Written Informed Consent Form
* Females that are not pregnant or breastfeeding with following condition: not a woman of childbearing potential or woman of childbearing potential using a highly effective contraception method
* Physician-diagnosis of asthma and documented evidence of airway reversibility during prior 24 months or during screening
* Airflow limitation as indicated by pre-BD FEV1 value: 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/11/2028
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
WB Contracted Clinical Research Site - Brookvale
Recruitment hospital [2] 0 0
WB Contracted Clinical Research Site - Coffs Harbour
Recruitment hospital [3] 0 0
WB Contracted Clinical Research Site - Maroubra
Recruitment hospital [4] 0 0
WB Contracted Clinical Research Site - Miranda
Recruitment hospital [5] 0 0
WB Contracted Clinical Research Site - Wollongong
Recruitment hospital [6] 0 0
WB Contracted Clinical Research Site - Birtinya
Recruitment hospital [7] 0 0
WB Contracted Clinical Research Site - North Altona
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
2228 - Miranda
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4575 - Birtinya
Recruitment postcode(s) [7] 0 0
3025 - North Altona
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires F.D.
Country [16] 0 0
Argentina
State/province [16] 0 0
Córdoba Province
Country [17] 0 0
Argentina
State/province [17] 0 0
Entre Ríos Province
Country [18] 0 0
Argentina
State/province [18] 0 0
Santa Fe Province
Country [19] 0 0
Argentina
State/province [19] 0 0
Tucumán Province
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Grad Sofia
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Lovech
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Ruse
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux
Country [25] 0 0
France
State/province [25] 0 0
Côte-dOr
Country [26] 0 0
France
State/province [26] 0 0
Hérault
Country [27] 0 0
France
State/province [27] 0 0
Isère
Country [28] 0 0
France
State/province [28] 0 0
Loire-Atlantique
Country [29] 0 0
Germany
State/province [29] 0 0
Loire-Atlantique
Country [30] 0 0
Germany
State/province [30] 0 0
Rhineland-Palatinate
Country [31] 0 0
Germany
State/province [31] 0 0
Schleswig-Holstein
Country [32] 0 0
Germany
State/province [32] 0 0
Darmstadt
Country [33] 0 0
Germany
State/province [33] 0 0
Frankfurt am Main
Country [34] 0 0
Germany
State/province [34] 0 0
Leipzig
Country [35] 0 0
Germany
State/province [35] 0 0
Mainz
Country [36] 0 0
Germany
State/province [36] 0 0
München
Country [37] 0 0
Spain
State/province [37] 0 0
Cádiz
Country [38] 0 0
Spain
State/province [38] 0 0
Entre Ríos
Country [39] 0 0
Spain
State/province [39] 0 0
Guipúzcoa
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Málaga
Country [42] 0 0
Spain
State/province [42] 0 0
Sevilla
Country [43] 0 0
Sweden
State/province [43] 0 0
Ostergotlands
Country [44] 0 0
Sweden
State/province [44] 0 0
Skåne County
Country [45] 0 0
Sweden
State/province [45] 0 0
Stockholm County

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Windward Bio
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Omar Khwaja, MD
Address 0 0
Windward Bio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ayshea Kring
Address 0 0
Country 0 0
Phone 0 0
+41 61 551 71 39
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07120503