Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 3:09 AM
Study NCT ID:
NCT05352893
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2022-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive a single intravenous (IV) high dose imsidolimab, low dose imsidolimab, or placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-04-25', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear)", 'timeFrame': 'week 4', 'description': 'Baseline to 0 (clear) or 1 (almost clear)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IL-36 Receptor', 'Interleukin 36', 'Imsidolimab'], 'conditions': ['Generalized Pustular Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).', 'detailedDescription': 'This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n-Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1\n\nExclusion Criteria:\n\n* Subject has other form of psoriasis excluding psoriasis vulgaris\n* Subject flare is so severe that patient's life is at risk"}, 'identificationModule': {'nctId': 'NCT05352893', 'acronym': 'GEMINI1', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis', 'orgStudyIdInfo': {'id': 'ANB019-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV high dose Imsidolimab, other name ANB019', 'description': 'ANB019 Biological Humanized Monoclonal Antibody High Dose', 'interventionNames': ['Drug: Imsidolimab high dose']}, {'type': 'EXPERIMENTAL', 'label': 'IV low dose Imsidolimab, other name ANB019', 'description': 'ANB019 Biological Humanized Monoclonal Antibody Low Dose', 'interventionNames': ['Drug: Imsidolimab low dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IV Placebo', 'description': 'Placebo Solution', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Imsidolimab high dose', 'type': 'DRUG', 'otherNames': ['ANB019'], 'description': 'intravenous', 'armGroupLabels': ['IV high dose Imsidolimab, other name ANB019']}, {'name': 'Imsidolimab low dose', 'type': 'DRUG', 'otherNames': ['ANB019'], 'description': 'intravenous', 'armGroupLabels': ['IV low dose Imsidolimab, other name ANB019']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'intravenous', 'armGroupLabels': ['IV Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33771', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 109', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '40056', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Site 105', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48108', 'city': 'Ann Arbor', 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'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}