Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-29 @ 1:25 PM
Study NCT ID:
NCT07120503
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events (TEAEs) during the study', 'timeFrame': 'Week 0 - Week 60'}, {'measure': 'Number of participants with treatment-emergent serious adverse events (TESAEs) during the study', 'timeFrame': 'Week 0 - Week 60'}, {'measure': 'Number of participants with abnormal vital signs during the study', 'timeFrame': 'Week 0 - Week 60'}, {'measure': 'Number of participants with abnormal laboratory assessments during the study', 'timeFrame': 'Week 0 - Week 60'}, {'measure': 'Number of participants with Clinically significant abnormal ECG results during the study', 'timeFrame': 'Week 0 - Week 60'}, {'measure': 'WIN 378 Pharmacokinetics: concentration at trough [Ctrough]', 'timeFrame': 'Week 0 - Week 60'}, {'measure': 'WIN 378 Pharmacokinetics: area under the concentration time curve [AUC]', 'timeFrame': 'Week 0 - Week 60'}, {'measure': 'WIN 378 Pharmacokinetics: maximum observed concentration [Cmax])', 'timeFrame': 'Week 0 - Week 60'}, {'measure': 'Number of participants with positive anti-drug antibodies (ADA) during the study', 'timeFrame': 'Week 0 - Week 60'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in FeNO at Week 24 and Week 48', 'timeFrame': 'Week 0 - Week 24, Week 48'}, {'measure': 'Change from Baseline in Blood eosinophil count at Week 24 and Week 48', 'timeFrame': 'Week 0 - Week 24, Week 48'}, {'measure': 'Change in pre-BD and post-BD FEV1 at Week 24 and Week 48', 'timeFrame': 'Week 0 - Week 24, Week 48'}, {'measure': 'Change in pre-BD and post-BD forced vital capacity (FVC) at Week 24 and Week 48', 'timeFrame': 'Week 0 - Week 24, Week 48'}, {'measure': 'Annualized asthma exacerbation rate (AAER) over 48 weeks', 'timeFrame': 'Week 0 - Week 48'}, {'measure': 'Annualized rate of severe asthma exacerbations over 48 weeks', 'timeFrame': 'Week 0 - Week 48'}, {'measure': 'Time to first asthma exacerbation/severe asthma exacerbation over 48 weeks', 'timeFrame': 'Week 0 - Week 48'}, {'measure': 'Proportion of participants with 1 or more asthma exacerbations/severe asthma exacerbations over 48 weeks', 'timeFrame': 'Week 0 - Week 48'}, {'measure': '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', 'timeFrame': 'Week 0 - Week 48'}, {'measure': 'Change from baseline in Asthma Control Questionnaire (ACQ-6) at Week 48', 'timeFrame': 'Week 0 - Week 48'}, {'measure': 'Change from baseline in Asthma Quality of Life Questionnaire (Standardised) + 12 at Week 48', 'timeFrame': 'Week 0 - Week 48'}, {'measure': 'Change from baseline in European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48', 'timeFrame': 'Week 0 - Week 48'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Moderate Asthma', 'Severe Asthma', 'Uncontrolled Asthma', 'Respiratory Diseases', 'Lung Diseases', 'Bronchial Diseases', 'Allergic Diseases'], 'conditions': ['Asthma (Diagnosis)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://windwardbio.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written Informed Consent Form\n* 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\n* Physician-diagnosis of asthma and documented evidence of airway reversibility during prior 24 months or during screening\n* Airflow limitation as indicated by pre-BD FEV1 value of ≥ 30% and ≤ 90%, predicted at two visits at Screening\n* Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)\n\nExclusion Criteria:\n\n* Participants with a known, pre-existing, clinically important lung condition other than asthma\n* Active tuberculosis or treatment required for tuberculosis within 12 months\n* Current or former smokers ≥10 pack years\n* History of cancer\n* 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\n* Helminth infection within 24 weeks prior to screening\n* Use of immunosuppressive medication within 3 months prior to Screening Visit or during the Screening Run-in period\n* Participants who are pregnant, lactating or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07120503', 'briefTitle': 'Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Windward Bio'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'WB-2101'}, 'secondaryIdInfos': [{'id': '2025-521391-58-00', 'type': 'CTIS'}, {'id': 'U1111-1319-6369', 'type': 'OTHER', 'domain': 'UTN, World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WIN378', 'description': 'WIN378 SC injections', 'interventionNames': ['Drug: WIN378']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo SC Injections', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'WIN378', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['WIN378']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A sham injection consisting of placebo to mask WIN378.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025-7014', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'WB Contracted Clinical Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95117', 'city': 'San Jose', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'WB Contracted Clinical Research Site', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '32763', 'city': 'Melbourne', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'WB Contracted Clinical Research Site', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'WB Contracted Clinical Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '21162', 'city': 'White Marsh', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'WB Contracted Clinical Research Site', 'geoPoint': {'lat': 39.38372, 'lon': -76.43218}}, {'zip': '98119', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'WB Contracted Clinical Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68123', 'city': 'Bellevue', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'WB Contracted Clinical Research Site', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'zip': '43560', 'city': 'Toledo', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'WB Contracted Clinical Research Site', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73034', 'city': 'Edmond', 'state': 'Oklahoma', 'status': 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'CONTACT', 'email': 'clinical.trial.enquiry@windwardbio.com', 'phone': '+41 61 551 71 39'}], 'overallOfficials': [{'name': 'Omar Khwaja, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Windward Bio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Windward Bio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}