Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT05399368
Status:
TERMINATED
Last Update Posted:
2024-06-14
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-05', 'mcpReleaseN': 18, 'releaseDate': '2025-05-21'}], 'estimatedResultsFirstSubmitDate': '2025-05-21'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'whyStopped': 'Study on clinical hold by FDA', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical efficacy', 'timeFrame': '16 weeks', 'description': '% change in Eczema Area Severity Index (EASI)'}, {'measure': 'Safety as measured by adverse events', 'timeFrame': '16 weeks', 'description': 'Incidence of treatment-emergent adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Phase 2 study of RPT193 in adults with atopic dermatitis', 'detailedDescription': 'Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria\n* 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening\n* inadequate response to a ≥1 month treatment with topical medications\n* Atopic dermatitis covering ≥10% of the body surface area\n* EASI score ≥16\n* Validated Investigator Global Assessment (VIGA) ≥3\n* Use of emollient(s) at least 2x daily for 1 week prior to baseline\n* Negative coronavirus disease (COVID)-19 results at screening\n\nExclusion Criteria:\n\n* Uncontrolled moderate-to-severe asthma\n* Uncontrolled diabetes\n* Stage III or IV cardiac failure\n* Severe renal condition\n* Major surgery within 8 weeks of screening\n* Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline\n* Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline\n* Received live or live-attenuated vaccine within 4 weeks of baseline\n* Prior receipt of RPT193'}, 'identificationModule': {'nctId': 'NCT05399368', 'briefTitle': 'An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'RAPT Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'RPT193-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RPT193 400 mg', 'description': 'RPT193 400 mg oral tablet administered daily for 16 weeks', 'interventionNames': ['Drug: RPT193']}, {'type': 'EXPERIMENTAL', 'label': 'RPT193 200 mg', 'description': 'RPT193 200 mg oral tablet administered daily for 16 weeks', 'interventionNames': ['Drug: RPT193']}, {'type': 'EXPERIMENTAL', 'label': 'RPT193 50 mg', 'description': 'RPT193 50 mg oral tablet administered daily for 16 weeks', 'interventionNames': ['Drug: RPT193']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo oral tablet administered daily for 16 weeks', '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 200 mg', 'RPT193 400 mg', 'RPT193 50 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Nonactive placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Dermatology and Skin Health Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85254', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Perseverance Research Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 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