Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-21 @ 1:28 PM
Study NCT ID:
NCT04693195
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2020-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000657411', 'term': 'BLU-5937'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm, parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'dispFirstSubmitDate': '2022-09-30', 'completionDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2020-12-30', 'dispFirstSubmitQcDate': '2022-10-13', 'studyFirstSubmitQcDate': '2020-12-30', 'dispFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score', 'timeFrame': 'Week 4', 'description': "Assessed by Worst Itch Numeric Rating Scale \\[WI-NRS\\]\n\nThe WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity."}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score', 'timeFrame': 'Week 4', 'description': "Assessed by Worst Itch Numeric Rating Scale \\[WI-NRS\\]\n\nThe WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity."}, {'measure': 'Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score', 'timeFrame': 'Week 4', 'description': "Assessed by Average Itch Numeric Rating Scale \\[AI-NRS\\]\n\nThe AI-NRS is a single item questionnaire assessing the patient-reported severity of itch overall (on average) during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity."}, {'measure': 'Change from baseline in Itching Quality of Life Survey (ItchyQOL)', 'timeFrame': 'Week 4', 'description': 'Assessed by Itching Quality of Life Survey \\[ItchyQOL\\]\n\nThe ItchyQOL is a 22-item questionnaire assessing the pruritus-specific disease burden on 3 domains: symptoms, functions and emotions. The responses to the frequency items are scored on a 1 (never) to 5 (all the time) scale. The recall period in ItchyQoL is the past week. Higher scores indicate a more adverse impact on quality of life.'}, {'measure': 'Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire', 'timeFrame': 'Week 4', 'description': "Assessed by Patient Global Impression of Change \\[PGIC\\]\n\nThe PGIC consists of 1 self-administered item that assesses the subject's impression of change in the severity of pruritus using a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher scores indicate a worsening of the severity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BLU-5937', 'Chronic Pruritus', 'Atopic Dermatitis', 'P2X3 receptor antagonist'], 'conditions': ['Chronic Pruritus', 'Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of BLU-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (AD).', 'detailedDescription': 'The study will consist of a 37-day Screening period (including a 7-day Run-In period), a 4-week Treatment period followed by a Follow-Up visit approximately 2 weeks after the last dose of study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to participate and is capable of giving informed consent\n* Clinically confirmed diagnosis of active AD with at least a 6-month history of AD\n* Chronic pruritus related to AD for at least 3 months\n* Moderate to severe itch associated with mild to moderate AD\n* Female of childbearing potential must agree to use a highly effective contraceptive method during the study and until at least 4 weeks after the last study drug administration\n\nExclusion Criteria:\n\n* History of skin disease or presence of skin condition that would interfere with the study assessments\n* Clearly defined etiology for pruritus other than AD, including but not limited to: urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection\n* Presence of any acute skin condition other than AD which may risk inducing a pruritus flare/worsening during the course of the study, including but not limited to: impetigo, active herpes simplex infection, or allergic contact dermatitis\n* Subject is \\>65 years of age and has developed pruritus at age of ≥50 years\n* History of cancer or lymphoproliferative disease within 5 years with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix\n* Known history of, or active, parasitic infection, including skin parasites such as scabies within 12 months prior to Screening\n* Known history of chronic infectious disease (e.g. hepatitis B, hepatitis C, or human immunodeficiency virus \\[HIV\\])\n* Known history of clinically significant drug or alcohol abuse in the last year\n* Previous participation in a BLU-5937 trial'}, 'identificationModule': {'nctId': 'NCT04693195', 'acronym': 'BLUEPRINT', 'briefTitle': 'A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bellus Health Inc. - a GSK company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety, and Tolerability of BLU-5937 for the Treatment of Chronic Pruritus in Adult Subjects With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'CL-PR-5937-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BLU-5937 oral tablet', 'description': 'Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.', 'interventionNames': ['Drug: BLU-5937']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo oral tablet', 'description': 'Eligible participants will receive matching Placebo BID orally for 4 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BLU-5937', 'type': 'DRUG', 'description': 'Oral administration of BLU-5937 tablets', 'armGroupLabels': ['BLU-5937 oral tablet']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration of matching placebo for BLU-5937 tablets', 'armGroupLabels': ['Placebo oral tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #28', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85254', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #10', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #23', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #33', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #27', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #35', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #15', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33063', 'city': 'Margate', 'state': 'Florida', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #32', 'geoPoint': {'lat': 26.24453, 'lon': -80.20644}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #16', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #19', 'geoPoint': {'lat': 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'70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #18', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #36', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #22', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #34', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #14', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '73071', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #29', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '19073', 'city': 'Newtown Square', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #37', 'geoPoint': {'lat': 39.98678, 'lon': -75.40103}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #41', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #12', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #31', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #40', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #11', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Bellus Health Investigational Site #25', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'G7H 7Y8', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Bellus Health Investigational Site #44', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'H2X 2V1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Bellus Health Investigational Site #20', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1N 4V3', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Bellus Health Investigational Site #43', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1W 4R4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Bellus Health Investigational Site #39', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1L 0H8', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Bellus Health Investigational Site #42', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bellus Health Inc. - a GSK company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}