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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521391-58-00 | EU Trial (CTIS) Number | ||
| U1111-1319-6369 | Other Identifier | UTN, World Health Organization (WHO) |
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This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate or severe asthma. WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms. The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy and pharmacokinetics of WIN378 in adult participants with moderate to severe asthma. Participants will continue their standard background asthma therapy according to GINA Steps 3-5. Eligible participants will be randomized to receive WIN378 or placebo administered subcutaneously over a 48-week treatment period, followed by a 12-week safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WIN378 | Experimental | WIN378 SC injections |
|
| Placebo | Experimental | Placebo SC Injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WIN378 | Drug | WIN378 is a fully human, long-acting monoclonal antibody that binds to thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving asthma control over an extended dosing interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) during the study | Week 0 - Week 60 | |
| Number of participants with treatment-emergent serious adverse events (TESAEs) during the study | Week 0 - Week 60 | |
| Number of participants with abnormal vital signs during the study | Week 0 - Week 60 | |
| Number of participants with abnormal laboratory assessments during the study | Week 0 - Week 60 | |
| Number of participants with Clinically significant abnormal ECG results during the study | Week 0 - Week 60 | |
| WIN 378 Pharmacokinetics: concentration at trough [Ctrough] | Week 0 - Week 60 | |
| WIN 378 Pharmacokinetics: area under the concentration time curve [AUC] | Week 0 - Week 60 | |
| WIN 378 Pharmacokinetics: maximum observed concentration [Cmax]) | Week 0 - Week 60 | |
| Number of participants with positive anti-drug antibodies (ADA) during the study | Week 0 - Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in FeNO at Week 24 and Week 48 | Week 0 - Week 24, Week 48 | |
| Change from Baseline in Blood eosinophil count at Week 24 and Week 48 | Week 0 - Week 24, Week 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Khwaja, MD | Windward Bio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WB Contracted Clinical Research Site | Los Angeles | California | 90025-7014 | United States | ||
| WB Contracted Clinical Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Double-blind
| Placebo | Drug | A sham injection consisting of placebo to mask WIN378. |
|
| Change in pre-BD and post-BD FEV1 at Week 24 and Week 48 |
| Week 0 - Week 24, Week 48 |
| Change in pre-BD and post-BD forced vital capacity (FVC) at Week 24 and Week 48 | Week 0 - Week 24, Week 48 |
| Annualized asthma exacerbation rate (AAER) over 48 weeks | Week 0 - Week 48 |
| Annualized rate of severe asthma exacerbations over 48 weeks | Week 0 - Week 48 |
| Time to first asthma exacerbation/severe asthma exacerbation over 48 weeks | Week 0 - Week 48 |
| Proportion of participants with 1 or more asthma exacerbations/severe asthma exacerbations over 48 weeks | Week 0 - Week 48 |
| 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 | Week 0 - Week 48 |
| Change from baseline in Asthma Control Questionnaire (ACQ-6) at Week 48 | Week 0 - Week 48 |
| Change from baseline in Asthma Quality of Life Questionnaire (Standardised) + 12 at Week 48 | Week 0 - Week 48 |
| Change from baseline in European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48 | Week 0 - Week 48 |
| San Jose |
| California |
| 95117 |
| United States |
| WB Contracted Clinical Research Site | Melbourne | Florida | 32763 | United States |
| WB Contracted Clinical Research Site | Miami | Florida | 33175 | United States |
| WB Contracted Clinical Research Site | White Marsh | Maryland | 21162 | United States |
| WB Contracted Clinical Research Site | Stow | Massachusetts | 01775-1205 | United States |
| WB Contracted Clinical Research Site | Detroit | Michigan | 48202-2608 | United States |
| WB Contracted Clinical Research Site | Richfield | Minnesota | 55423-2477 | United States |
| WB Contracted Clinical Research Site | St Louis | Missouri | 98119 | United States |
| WB Contracted Clinical Research Site | Bellevue | Nebraska | 68123 | United States |
| WB Contracted Clinical Research Site | Toledo | Ohio | 43560 | United States |
| WB Contracted Clinical Research Site | Edmond | Oklahoma | 73034 | United States |
| WB Contracted Clinical Research Site | Pittsburgh | Pennsylvania | 15213-3236 | United States |
| WB Contracted Clinical Research Site | Charleston | South Carolina | 29420 | United States |
| WB Contracted Clinical Research Site | Spartanburg | South Carolina | 29303 | United States |
| WB Contracted Clinical Research Site | Austin | Texas | 78730 | United States |
| WB Contracted Clinical Research Site | El Paso | Texas | 79903 | United States |
| WB Contracted Clinical Research Site | McKinney | Texas | 75069-8085 | United States |
| WB Contracted Clinical Research Site | San Antonio | Texas | 78229 | United States |
| WB Contracted Clinical Research Site | Tyler | Texas | 75708-3154 | United States |
| WB Contracted Clinical Research Site | Richmond | Virginia | 23226 | United States |
| WB Contracted Clinical Research Site | Buenos Aires | Buenos Aires F.D. | C1023AAB | Argentina |
| WB Contracted Clinical Research Site | Buenos Aires | Buenos Aires F.D. | C1121ABE | Argentina |
| WB Contracted Clinical Research Site | Buenos Aires | Buenos Aires F.D. | C1414AIF | Argentina |
| WB Contracted Clinical Research Site | Buenos Aires | Buenos Aires F.D. | C1425BEN | Argentina |
| WB Contracted Clinical Research Site | Buenos Aires | Buenos Aires F.D. | C1425FVH | Argentina |
| WB Contracted Clinical Research Site | Buenos Aires | Buenos Aires F.D. | C1426ABP | Argentina |
| WB Contracted Clinical Research Site | Córdoba | Córdoba Province | X5003DCE | Argentina |
| WB Contracted Clinical Research Site | Paraná | Entre Ríos Province | E3102ADP | Argentina |
| WB Contracted Clinical Research Site | Rosario | Santa Fe Province | S2000BRH | Argentina |
| WB Contracted Clinical Research Site | Rosario | Santa Fe Province | S2013KZD | Argentina |
| WB Contracted Clinical Research Site | Santa Fe | Santa Fe Province | S3000ASF | Argentina |
| WB Contracted Clinical Research Site | San Miguel de Tucumán | Tucumán Province | T4000CBC | Argentina |
| WB Contracted Clinical Research Site | San Miguel de Tucumán | Tucumán Province | T4000IAP | Argentina |
| WB Contracted Clinical Research Site | San Miguel de Tucumán | Tucumán Province | T4000IFL | Argentina |
| WB Contracted Clinical Research Site | Brookvale | New South Wales | 2100 | Australia |
| WB Contracted Clinical Research Site | Coffs Harbour | New South Wales | 2450 | Australia |
| WB Contracted Clinical Research Site | Maroubra | New South Wales | 2035 | Australia |
| WB Contracted Clinical Research Site | Miranda | New South Wales | 2228 | Australia |
| WB Contracted Clinical Research Site | Wollongong | New South Wales | 2500 | Australia |
| WB Contracted Clinical Research Site | Birtinya | Queensland | 4575 | Australia |
| WB Contracted Clinical Research Site | North Altona | Victoria | 3025 | Australia |
| WB Contracted Clinical Research Site | Sofia | Grad Sofia | 1407 | Bulgaria |
| WB Contracted Clinical Research Site | Lovech | Lovech | 5500 | Bulgaria |
| WB Contracted Clinical Research Site | Rousse | Ruse | 7000 | Bulgaria |
| WB Contracted Clinical Research Site | Sofia | Sofia | 1233 | Bulgaria |
| WB Contracted Clinical Research Site | Sofia | Sofia | 1680 | Bulgaria |
| WB Contracted Clinical Research Site | Pessac | Bordeaux | 33000 | France |
| WB Contracted Clinical Research Site | Dijon | Côte-dOr | 21000 | France |
| WB Contracted Clinical Research Site | Montpellier | Hérault | 34090 | France |
| WB Contracted Clinical Research Site | La Tronche | Isère | 38700 | France |
| WB Contracted Clinical Research Site | Nantes | Loire-Atlantique | 44093 | France |
| WB Contracted Clinical Research Site | Berlin | Loire-Atlantique | 10119 | Germany |
| WB Contracted Clinical Research Site | München | Loire-Atlantique | 80539 | Germany |
| WB Contracted Clinical Research Site | Bendorf | Rhineland-Palatinate | 56170 | Germany |
| WB Contracted Clinical Research Site | Lübeck | Schleswig-Holstein | 23552 | Germany |
| WB Contracted Clinical Research Site | Darmstadt | 64283 | Germany |
| WB Contracted Clinical Research Site | Frankfurt am Main | 60389 | Germany |
| WB Contracted Clinical Research Site | Frankfurt am Main | 60596 | Germany |
| WB Contracted Clinical Research Site | Leipzig | 4347 | Germany |
| WB Contracted Clinical Research Site | Mainz | 55128 | Germany |
| WB Contracted Clinical Research Site | München | 81241 | Germany |
| WB Contracted Clinical Research Site | Chiclana de la Frontera | Cádiz | 11139 | Spain |
| WB Contracted Clinical Research Site | Madrid | Entre Ríos | 28003 | Spain |
| WB Contracted Clinical Research Site | San Sebastián | Guipúzcoa | 20014 | Spain |
| WB Contracted Clinical Research Site | Madrid | Madrid | 28050 | Spain |
| WB Contracted Clinical Research Site | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| WB Contracted Clinical Research Site | Benalmádena | Málaga | 29639 | Spain |
| WB Contracted Clinical Research Site | Málaga | Málaga | 29010 | Spain |
| WB Contracted Clinical Research Site | Seville | Sevilla | 41012 | Spain |
| WB Contracted Clinical Research Site | Linköping | Ostergotlands | 587 58 | Sweden |
| WB Contracted Clinical Research Site | Malmö | Skåne County | 20512 | Sweden |
| WB Contracted Clinical Research Site | Stockholm | Stockholm County | 11239 | Sweden |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004194 | Disease |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D001982 | Bronchial Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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