Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT06603220
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2024-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094482', 'term': 'Chronic Inducible Urticaria'}], 'ancestors': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'Day 1 to Week 6', 'description': 'Safety will be assessed through an evaluation of treatment emergent adverse events, physical exams, vital signs, laboratory tests, and 12-lead ECGs.'}], 'secondaryOutcomes': [{'measure': 'Change in Total Fric Score (TFS)', 'timeFrame': 'Day 1 to Week 4', 'description': 'Changes in the number of prongs that elicit a wheal response using a FricTest for subjects with symptomatic dermographism.'}, {'measure': 'Change in Critical Temperature Threshold (CTT)', 'timeFrame': 'Day 1 to Week 4', 'description': 'Changes in the highest temperature that elicits a wheal response using a TempTest for subjects with cold urticaria.'}, {'measure': 'Change in pruritus severity at the provocation test site', 'timeFrame': 'Day 1 to Week 4', 'description': 'Changes in the severity of pruritus at the provocation test site using an 11-point numerical rating scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic inducible urticaria', 'inducible urticaria'], 'conditions': ['Chronic Inducible Urticaria']}, 'descriptionModule': {'briefSummary': 'This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold urticaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of chronic inducible urticaria for at least 3 months.\n* Positive response following provocation using the TempTest or FricTest at Screening and Day 1.\n\nExclusion Criteria:\n\n* History of diseases other than chronic inducible urticaria or chronic spontaneous urticaria with urticaria or angioedema symptoms, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema.\n* Concurrent use of certain medications, including antihistamines.\n* Any clinically significant disease, or other skin disease or skin markings (e.g., extensive scarring, tattoos), that might confound the evaluation of safety or efficacy.'}, 'identificationModule': {'nctId': 'NCT06603220', 'briefTitle': 'A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evommune, Inc.'}, 'officialTitle': 'An Open Label Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria', 'orgStudyIdInfo': {'id': 'EVO756-CIU001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EVO756', 'interventionNames': ['Drug: Oral EVO756']}], 'interventions': [{'name': 'Oral EVO756', 'type': 'DRUG', 'description': 'Oral EVO756, once daily', 'armGroupLabels': ['EVO756']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Dermatology & Skin Health Center, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Allergy and Asthma Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin Science and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'West Dermatology Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Aeroallergy Research Laboratories of Savannah, Inc.', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Treasure Valley Medical Research', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'Southern Indiana Clinical Trials', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Clinical Trials Center, P.C.', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'DelRicht Research', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21162', 'city': 'White Marsh', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Clinical Research, Inc', 'geoPoint': {'lat': 39.38372, 'lon': -76.43218}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'OptiSkin Medical', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '58013', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Red River Research Partners', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43209', 'city': 'Bexley', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bexley Dermatology Research', 'geoPoint': {'lat': 39.96895, 'lon': -82.93768}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Allergy, Asthma, and Clinical Research Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allergy and Clinical Immunology Associates', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Institute for Clinical Research', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evommune, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}