Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT06931405
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094482', 'term': 'Chronic Inducible Urticaria'}, {'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D000096703', 'term': 'Cold Urticaria'}, {'id': 'C536612', 'term': 'Familial dermographism'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Arms A1 and A3 are non-randomized and open label. Arm B is randomized and double blind.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 through Week 16'}], 'secondaryOutcomes': [{'measure': 'Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'CTT is the temperature at which CIndU symptoms appear.'}, {'measure': 'Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'TFS is a measure of CIndU trigger thresholds and disease activity.'}, {'measure': 'Part A and Part B: Complete Response Rate', 'timeFrame': 'Week 12'}, {'measure': 'Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Part A and Part B: Area Under the Curve (AUC) of BLU-808', 'timeFrame': 'Day 1 to Day 57'}, {'measure': 'Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808', 'timeFrame': 'Day 1 to Day 57'}, {'measure': 'Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808', 'timeFrame': 'Day 1 to Day 57'}, {'measure': 'Part A and Part B: Apparent Clearance (CL/F) of BLU-808', 'timeFrame': 'Day 1 to Day 57'}, {'measure': 'Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808', 'timeFrame': 'Day 1 to Day 57'}, {'measure': 'Part A and Part B: Terminal Half-life (t½) of BLU-808', 'timeFrame': 'Day 1 to Day 57'}, {'measure': 'Part B: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'UAS7 is a patient-reported outcome used to assess symptoms in participants with CSU.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Inducible Urticaria', 'Chronic Spontaneous Urticaria', 'BLU-808', 'CIndU', 'CSU', 'Chronic Urticaria', 'CU', 'Cold Urticaria', 'ColdU', 'Symptomatic Dermographism', 'SD'], 'conditions': ['Chronic Inducible Urticaria', 'Chronic Spontaneous Urticaria']}, 'descriptionModule': {'briefSummary': 'This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.\n* Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.\n\nKey Exclusion Criteria:\n\n* Part A: Any active urticaria that may interfere with study assessments.\n* Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria.\n* Part A and Part B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions.\n* Part A and Part B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results.\n* Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation.\n* Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06931405', 'briefTitle': 'Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Blueprint Medicines Corporation'}, 'officialTitle': 'A Phase 2 Study to Evaluate the Safety, Tolerability, and Clinical Activity of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria', 'orgStudyIdInfo': {'id': 'BLU-808-1201'}, 'secondaryIdInfos': [{'id': '2024-520031-33-00', 'type': 'OTHER', 'domain': 'Clinical Trials Information System (CTIS)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A1 (Part A): BLU-808', 'description': 'BLU-808 will be administered orally.', 'interventionNames': ['Drug: BLU-808']}, {'type': 'EXPERIMENTAL', 'label': 'Arm A3 (Part A): BLU-808', 'description': 'BLU-808 will be administered orally.', 'interventionNames': ['Drug: BLU-808']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (Part B): BLU-808/Placebo', 'description': 'BLU-808 or matching placebo will be administered orally.', 'interventionNames': ['Drug: BLU-808', 'Drug: Placebo']}], 'interventions': [{'name': 'BLU-808', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Arm A1 (Part A): BLU-808', 'Arm A3 (Part A): BLU-808', 'Arm B (Part B): BLU-808/Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Arm B (Part B): BLU-808/Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Allervie Clinical Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Acuro Research, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Modena Allergy & Asthma Clinical Research - La Jolla', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92677', 'city': 'Laguna Niguel', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Allergy & Asthma Associates of Southern California', 'geoPoint': {'lat': 33.52253, 'lon': -117.70755}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Allergy & Asthma Medical Group and Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Allergy Affiliates Inc.', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Treasure Valley Medical Research', 'geoPoint': {'lat': 43.6135, 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