Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:25 PM
Study NCT ID:
NCT06555328
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2024-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'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'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).', 'timeFrame': 'Through study completion, an average of 10 weeks', 'description': 'Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) using MedDRA classification.'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration [Cmax]', 'timeFrame': 'Through study completion, an average of 10 weeks', 'description': 'Plasma PK parameters of INF904'}, {'measure': 'Minimum Plasma Concentration [Cmin]', 'timeFrame': 'Through study completion, an average of 10 weeks', 'description': 'Plasma PK parameters of INF904'}, {'measure': 'Time of occurrence of maximum plasma concentration [tmax]', 'timeFrame': 'Through study completion, an average of 10 weeks', 'description': 'Plasma PK parameters of INF904'}, {'measure': 'Systemic exposure, defined as the Area Under the Curve [AUC0-24]', 'timeFrame': 'Through study completion, an average of 10 weeks', 'description': 'Plasma PK parameters of INF904'}, {'measure': 'Systemic exposure, defined as the Area Under the Curve [AUClast]', 'timeFrame': 'Through study completion, an average of 10 weeks', 'description': 'Plasma PK parameters of INF904'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Urticaria, Idiopathic', 'Hidradenitis', 'Hidradenitis Suppurativa']}, 'descriptionModule': {'briefSummary': 'The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent.\n* Subjects must be 18 years or older at the time of signing the informed consent.\n\nExclusion Criteria:\n\n* Subjects with known severe or life-threatening hypersensitivity reaction to any other CSU/HS treatment according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).\n* Subjects who have any other skin disease that may interfere with assessment of CSU or HS.\n* Subjects who have an active infection or history of infection(s) as follows:\n\n 1. Any infection requiring systemic treatment within 14 days prior to baseline.\n 2. A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.\n* Subjects with known progressed liver disease (Child-Pugh B or C)'}, 'identificationModule': {'nctId': 'NCT06555328', 'briefTitle': 'Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa', 'organization': {'class': 'INDUSTRY', 'fullName': 'InflaRx GmbH'}, 'officialTitle': 'Phase 2a Open-Label Basket Study to Evaluate Safety and Pharmacokinetics of INF904, an Oral C5aR1 Inhibitor, in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': 'INF904- P2.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 CSU', 'description': 'Lower dose of IFN904 BID', 'interventionNames': ['Drug: CSU lower dose treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 CSU', 'description': 'Higher dose of IFN904 BID', 'interventionNames': ['Drug: CSU high dose treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 CSU', 'description': 'Non responders IgE, higher dose of IFN904 BID', 'interventionNames': ['Drug: CSU non responders IgE - high dose treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4 HS', 'description': 'Lower dose of IFN904 BID', 'interventionNames': ['Drug: HS low dose treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5 HD', 'description': 'Medium dose of IFN904 BID', 'interventionNames': ['Drug: HS medium dose treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6 HD', 'description': 'High dose of IFN904 BID', 'interventionNames': ['Drug: HS high dose treatment']}], 'interventions': [{'name': 'CSU lower dose treatment', 'type': 'DRUG', 'description': 'CSU lower dose treatment', 'armGroupLabels': ['Arm 1 CSU']}, {'name': 'CSU high dose treatment', 'type': 'DRUG', 'description': 'CSU high dose treatment', 'armGroupLabels': ['Arm 2 CSU']}, {'name': 'CSU non responders IgE - high dose treatment', 'type': 'DRUG', 'description': 'CSU non responders IgE - high dose treatment', 'armGroupLabels': ['Arm 3 CSU']}, {'name': 'HS low dose treatment', 'type': 'DRUG', 'description': 'HS low dose treatment', 'armGroupLabels': ['Arm 4 HS']}, {'name': 'HS medium dose treatment', 'type': 'DRUG', 'description': 'HS medium dose treatment', 'armGroupLabels': ['Arm 5 HD']}, {'name': 'HS high dose treatment', 'type': 'DRUG', 'description': 'HS high dose treatment', 'armGroupLabels': ['Arm 6 HD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'First OC Dermatology Research Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ziaderm Research LLC', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ForCare Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '42071', 'city': 'Murray', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Kentucky Advanced Medical Research LLC', 'geoPoint': {'lat': 36.61033, 'lon': -88.31476}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MediSearch LLC', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '11415', 'city': 'Kew Gardens', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Forest Hills Dermatology Group', 'geoPoint': {'lat': 40.71427, 'lon': -73.83097}}, {'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Wright State Physicians', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}, {'zip': '78213', 'city': 'Texas City', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Progressive Clinical Research, PA', 'geoPoint': {'lat': 29.38385, 'lon': -94.9027}}, {'zip': '5500', 'city': 'Lovech', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Medical Center Medconsult, Pleven OOD', 'geoPoint': {'lat': 43.13227, 'lon': 24.71763}}, {'zip': '5800', 'city': 'Pleven', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Medical Center Medconsult pleven OOD', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4200', 'city': 'Plovdiv', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Medical Center Etika', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1407', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'ASMC IPSMC Skin and Venereal Diseases,', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1407', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Medical Center Excelsior OOD,', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6010', 'city': 'Batumi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'LTD "Health"', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'zip': '0112', 'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'LTD "Israel-Georgian Medical Research Clinic Healthycore"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'LLC "Center of Allergy and Immunology"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'LLC "Aversi Clinic"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '12203', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': '"Institut Allergieforschung Charité - Universitatsmedizin Berlin"', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitatsklinikum Dresden Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60950', 'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '80337', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'facility': '"Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie"', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '12462', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'General University Hospital "Attikon"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '56403', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'General Hospital of Thessaloniki "Papageorgiou"', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '80-214', 'city': 'Gdansk', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '90-153', 'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '42-624', 'city': 'Ossy', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Labderm Essence sp.', 'geoPoint': {'lat': 50.43717, 'lon': 18.99921}}, {'zip': '50-566', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'facility': '"Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Eva Wagner, PhD', 'role': 'CONTACT', 'email': 'clinicaltrials@inflarx.de; clinicaltrials@inflarx.com', 'phone': '+49 (0) 3641 508 180'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InflaRx GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}