Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-07 @ 3:30 AM
Study NCT ID:
NCT05935332
Status:
TERMINATED
Last Update Posted:
2024-07-22
First Post:
2023-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-12', 'mcpReleaseN': 9, 'releaseDate': '2025-05-28'}], 'estimatedResultsFirstSubmitDate': '2025-05-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Study on clinical hold by FDA', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with a Loss of Asthma Control event as defined by criteria listed', 'timeFrame': '14 weeks', 'description': '≥ 30% reduction in peak expiratory flow; ≥ 6 additional inhalations of short-acting beta 2 agonist; increase by factor of 4 or more of inhaled corticosteroids; and/or evidence of a severe asthma exacerbation'}], 'secondaryOutcomes': [{'measure': 'Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0', 'timeFrame': '20 weeks', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).', 'detailedDescription': 'Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).\n\nAfter a screening period subjects will receive standardized, inhaled therapy during a run-in period. Subjects will be randomized to receive RPT193 or placebo through Week 14. All enrolled subjects will receive background inhaled therapy with ICS and LABA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosis of asthma for ≥6 months\n* Pre-bronchodilator FEV1 of \\>40% and \\<80%\n* History of treatment with corticosteroid or hospitalization for worsening asthma\n* Medium- or high-dose inhaled corticosteroid use\n\nExclusion Criteria:\n\n* History of smoking/vaping\n* History of severe COVID\n* Serious and/or uncontrolled pulmonary, cardiac, immune system conditions\n* Requires systemic oral or IV corticosteroids in the month prior to screening'}, 'identificationModule': {'nctId': 'NCT05935332', 'briefTitle': 'Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'RAPT Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 in Adults With Moderate-to-severe T2-high Asthma Who Are Partially Controlled on Inhaled Corticosteroid and Long-acting Beta 2 Agonist Therapy', 'orgStudyIdInfo': {'id': 'RPT193-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RPT193 400 mg', 'interventionNames': ['Drug: RPT193']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'RPT193', 'type': 'DRUG', 'description': 'RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17', 'armGroupLabels': ['RPT193 400 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95117', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Associates of Santa Clara Valley Research Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95207', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Bensch Clinical Research LLC', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '92683', 'city': 'Westminster', 'state': 'California', 'country': 'United States', 'facility': 'Allianz Research Institute', 'geoPoint': {'lat': 33.75918, 'lon': -118.00673}}, {'zip': '80014', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Allianz Research Institute CO', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sonce Medical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Coral Research Clinical Corp', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'San Marcos Research Clinic', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Trials of Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '73034', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OK Clinical Research LLC', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '97527', 'city': 'Grants Pass', 'state': 'Oregon', 'country': 'United States', 'facility': 'Velocity Clinical Research Grants Pass', 'geoPoint': {'lat': 42.43933, 'lon': -123.33067}}, {'zip': '79903', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Western Sky Medical Research', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '95069', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Pulmonary & Sleep Center', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '53228', 'city': 'Greenfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Allergy, Asthma & Sinus Ceneter SC', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}, {'zip': '3320', 'city': 'Kozloduy', 'country': 'Bulgaria', 'facility': 'Medical Center "Zadrave-1"', 'geoPoint': {'lat': 43.77691, 'lon': 23.73001}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Center Excelsior', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1680', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Diagnostic-Consultative Center Convex Ltd.', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6003', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '9000', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Medical Center "ResearchExpert" Ltd', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '3000', 'city': 'Vratsa', 'country': 'Bulgaria', 'facility': 'Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Vratsa', 'geoPoint': {'lat': 43.21052, 'lon': 23.56312}}, {'zip': '377 01', 'city': 'Jindřichův Hradec', 'country': 'Czechia', 'facility': 'MediTrial s.r.o', 'geoPoint': {'lat': 49.14404, 'lon': 15.00301}}, {'zip': '02-482', 'city': 'Warsaw', 'state': 'Solipska', 'country': 'Poland', 'facility': 'Trialmed Sp z. o.o.o CRS Warszawa', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '15-044', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Centrum Medycyny Oddechowej Mróz Spółka Jawna', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '31-159', 'city': 'Krakow', 'country': 'Poland', 'facility': 'NZOZ Poradnie Specjalistyczne Atopia', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-752', 'city': 'Lodz', 'country': 'Poland', 'facility': 'IP Clinic Sp. z.o.o', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '59-300', 'city': 'Lubin', 'country': 'Poland', 'facility': 'Centrum Diagnostyczno Terapeutyczne MEDICUS Sp. z o.o. - Szpital', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'zip': '97-300', 'city': 'Piotrkow Trybunalski', 'country': 'Poland', 'facility': 'Trialmed CRS (Piotrków Trybunalski)', 'geoPoint': {'lat': 51.40547, 'lon': 19.70321}}, {'zip': '61-578', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '53-301', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Michal Bogacki - Dobrostan', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '54-239', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Lekarze Specjaliści - J. Małolepszy i Partnerzy', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Laurence Cheng, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RAPT Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAPT Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}