Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

Last updated: April 3, 2026
Sponsor: Windward Bio
Overall Status: Active - Not Recruiting

Phase

2

Condition

Asthma

Treatment

Placebo

WIN378

Clinical Study ID

NCT07120503
WB-2101
2025-521391-58-00
U1111-1319-6369
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written Informed Consent Form

  • Females that are not pregnant or breastfeeding with following condition: not a womanof childbearing potential or woman of childbearing potential using a highlyeffective contraception method

  • Physician-diagnosis of asthma and documented evidence of airway reversibility duringprior 24 months or during screening

  • Airflow limitation as indicated by pre-BD FEV1 value of ≥ 30% and ≤ 90%, predictedat two visits at Screening

  • Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)

Exclusion

Exclusion Criteria:

  • Participants with a known, pre-existing, clinically important lung condition otherthan asthma

  • Active 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 toscreening; receipt of immunoglobulin or blood products within 30 days prior toscreening or during the Screening Run-in period; receipt of any live or attenuatedvaccines 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 orduring the Screening Run-in period

  • Participants who are pregnant, lactating or breastfeeding

Study Design

Total Participants: 136
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 24, 2025
Estimated Completion Date:
October 31, 2027

Study Description

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.

Connect with a study center

  • WB Contracted Clinical Research Site

    Buenos Aires, Buenos Aires F.D. C1426ABP
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1121ABE
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    Córdoba, Córdoba Province X5003DCE
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    Córdoba 3860259, Córdoba Province 3860255 X5003DCE
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    Paraná, Entre Ríos Province E3102ADP
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    Rosario, Santa Fe Province S2000BRH
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    Santa Fe, Santa Fe Province S3000ASF
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    Santa Fe 3836277, Santa Fe Province 3836276 S3000ASF
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    San Miguel de Tucumán, Tucumán Province T4000CBC
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000IAP
    Argentina

    Site Not Available

  • WB Contracted Clinical Research Site

    Brookvale, New South Wales 2100
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Coffs Harbour, New South Wales 2450
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Maroubra, New South Wales 2035
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Miranda, New South Wales 2228
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Brookvale 2208303, New South Wales 2155400 2100
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Coffs Harbour 2171085, New South Wales 2155400 2450
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Maroubra 2158651, New South Wales 2155400 2035
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Miranda 2157495, New South Wales 2155400 2228
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Wollongong 2171507, New South Wales 2155400 2500
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Birtinya, Queensland 4575
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    North Altona, Victoria 3025
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    North Altona 8298607, Victoria 2145234 3025
    Australia

    Site Not Available

  • WB Contracted Clinical Research Site

    Sofia 727011, Grad Sofia 1407
    Bulgaria

    Site Not Available

  • WB Contracted Clinical Research Site

    Lovech, Lovech 5500
    Bulgaria

    Site Not Available

  • WB Contracted Clinical Research Site

    Lovech 729559, Lovech 729560 5500
    Bulgaria

    Site Not Available

  • WB Contracted Clinical Research Site

    Rousse, Ruse 7000
    Bulgaria

    Site Not Available

  • WB Contracted Clinical Research Site

    Rousse 727523, Ruse 727524 7000
    Bulgaria

    Site Not Available

  • WB Contracted Clinical Research Site

    Sofia, Sofia 1680
    Bulgaria

    Site Not Available

  • WB Contracted Clinical Research Site

    Pessac, Bordeaux 33000
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    Pessac 2987805, Bordeaux 33000
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    Dijon, Côte-dOr 21000
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    Dijon 3021372, Côte-dOr 21000
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    Montpellier, Hérault 34090
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    Montpellier 2992166, Hérault 34090
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    La Tronche, Isère 38700
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    La Tronche 3006131, Isère 38700
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    Nantes, Loire-Atlantique 44093
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    Nantes 2990969, Loire-Atlantique 44093
    France

    Site Not Available

  • WB Contracted Clinical Research Site

    Berlin, Loire-Atlantique 10119
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Berlin 2950159, Loire-Atlantique 10119
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Bendorf, Rhineland-Palatinate 56170
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Bendorf 2951111, Rhineland-Palatinate 2847618 56170
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Lübeck, Schleswig-Holstein 23552
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Darmstadt, 64283
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Darmstadt 2938913, 64283
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Frankfurt am Main, 60389
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Frankfurt am Main 2925533, 60596
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Leipzig, 4347
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Leipzig 2879139, 4347
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Mainz, 55128
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Mainz 2874225, 55128
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    München, 81241
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    München 2867711, 81241
    Germany

    Site Not Available

  • WB Contracted Clinical Research Site

    Chiclana de la Frontera, Cádiz 11139
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Chiclana de la Frontera 2519513, Cádiz 11139
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Madrid, Entre Ríos 28003
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    San Sebastián, Guipúzcoa 20014
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    San Sebastián 3110043, Guipúzcoa 20014
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Pozuelo de Alarcón, Madrid 28223
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Madrid 3117735, Madrid 3117732 28050
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Pozuelo de Alarcón 3112989, Madrid 3117732 28223
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Benalmádena, Málaga 29639
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Benalmádena 2521139, Málaga 29639
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Málaga, Málaga 29010
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Málaga 2514256, Málaga 29010
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Seville, Sevilla 41012
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Seville 2510911, Sevilla 41012
    Spain

    Site Not Available

  • WB Contracted Clinical Research Site

    Linköping, Ostergotlands 587 58
    Sweden

    Site Not Available

  • WB Contracted Clinical Research Site

    Linköping 2694762, Ostergotlands 587 58
    Sweden

    Site Not Available

  • WB Contracted Clinical Research Site

    Malmo, Skåne County 20512
    Sweden

    Site Not Available

  • WB Contracted Clinical Research Site

    Malmo 2692969, Skåne County 3337385 20512
    Sweden

    Site Not Available

  • WB Contracted Clinical Research Site

    Stockholm, Stockholm County 11239
    Sweden

    Site Not Available

  • WB Contracted Clinical Research Site

    Stockholm 2673730, Stockholm County 2673722 11239
    Sweden

    Site Not Available

  • WB Contracted Clinical Research Site

    Los Angeles, California 90025-7014
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    San Jose, California 95117
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Los Angeles 5368361, California 5332921 90025-7014
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    San Jose 5392171, California 5332921 95117
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Melbourne, Florida 32763
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Miami, Florida 33175
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Melbourne 4163971, Florida 4155751 32763
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Miami 4164138, Florida 4155751 33175
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    White Marsh, Maryland 21162
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    White Marsh 4373426, Maryland 4361885 21162
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Stow, Massachusetts 01775-1205
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Detroit, Michigan 48202-2608
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Richfield, Minnesota 55423-2477
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Richfield 5043193, Minnesota 5037779 55423-2477
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    St Louis, Missouri 98119
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    St Louis 4407066, Missouri 4398678 98119
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Bellevue, Nebraska 68123
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Bellevue 5063805, Nebraska 5073708 68123
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Toledo, Ohio 43560
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Toledo 5174035, Ohio 5165418 43560
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Edmond, Oklahoma 73034
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Edmond 4535740, Oklahoma 4544379 73034
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Pittsburgh, Pennsylvania 15213-3236
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Charleston, South Carolina 29420
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Charleston 4574324, South Carolina 4597040 29420
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Spartanburg 4597200, South Carolina 4597040 29303
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Austin, Texas 78730
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    El Paso, Texas 79903
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    McKinney, Texas 75069-8085
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Tyler, Texas 75708-3154
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Austin 4671654, Texas 4736286 78730
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    El Paso 5520993, Texas 4736286 79903
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    McKinney 4710178, Texas 4736286 75069-8085
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Tyler 4738214, Texas 4736286 75708-3154
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Richmond, Virginia 23226
    United States

    Site Not Available

  • WB Contracted Clinical Research Site

    Richmond 4781708, Virginia 6254928 23226
    United States

    Site Not Available

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