Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT05732402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2023-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Norway', 'Spain', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}, {'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D055953', 'term': 'Microscopic Polyangiitis'}, {'id': 'D014890', 'term': 'Granulomatosis with Polyangiitis'}, {'id': 'D015267', 'term': 'Churg-Strauss Syndrome'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006099', 'term': 'Granuloma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Study Day 1 Through 24 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part B: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Study Day 1 Through 12 Weeks After Last Dose Of Study Drug'}], 'secondaryOutcomes': [{'measure': 'Part A: Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept', 'timeFrame': 'Study Day 1 Through 24 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part B: Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept', 'timeFrame': 'Study Day 1 Through 12 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part A: Time Required for Povetacicept To Reach Half its Concentration (t1/2)', 'timeFrame': 'Study Day 1 Through 24 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part B: Time Required for Povetacicept To Reach Half its Concentration (t1/2)', 'timeFrame': 'Study Day 1 Through 12 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part A: Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE).', 'timeFrame': 'Study Day 1 Through 24 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part B: Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE)', 'timeFrame': 'Study Day 1 Through 12 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part A: Change from Baseline in Peripheral Blood Lymphocytes and Subsets', 'timeFrame': 'Study Day 1 Through 24 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part B: Change from Baseline in Peripheral Blood Lymphocytes and Subsets', 'timeFrame': 'Study Day 1 Through 12 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part A:Change from Baseline Over Time In Circulating Levels Of anti-dsDNA in LN; galactose deficient IgA1 (Gd-IgA1) and anti-Gd-IgA1 in IgAN; anti-PLA2R1 or anti THSD7A in pMN and anti-PR3 or anti-MPO in AAV', 'timeFrame': 'Study Day 1 Through 24 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part B: Change from Baseline Over Time In Circulating Levels Of galactose deficient IgA1 (Gd-IgA1) and anti-Gd-IgA1 in IgAN; anti-PLA2R1 or anti THSD7A in pMN', 'timeFrame': 'Study Day 1 Through 12 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part A: Change From Baseline Over Time In Complement Components (C3, C4, CH50)', 'timeFrame': 'Study Day 1 Through 24 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part B: Change From Baseline Over Time In Complement Components (C3, C4, CH50)', 'timeFrame': 'Study Day 1 Through 12 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part A: Immunological Remission (pMN only)', 'timeFrame': 'Study Day 1 Through Week 24 After Dose of Study Drug'}, {'measure': 'Part B: Immunological Remission (pMN only)', 'timeFrame': 'Study Day 1 Through Week 12 After Dose of Study Drug'}, {'measure': 'Part A: Change from Baseline at Week 24 in UPCR (Urine protein/creatinine ratio) (based on assessment of 24-hour urine)', 'timeFrame': 'Baseline and at Week 24'}, {'measure': 'Part A: Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline and at Week 24'}, {'measure': 'Part B: Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline and at Week 24'}, {'measure': 'Part A: Renal Response', 'timeFrame': 'At Week 24'}, {'measure': 'Part A: Remission of Vasculitis (Birmingham Vasculitis Activity Score (BVAS = 0)) (for AAV cohorts only)', 'timeFrame': 'At Week 24'}, {'measure': 'Part A: Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept', 'timeFrame': 'Study Day 1 Through 24 Weeks After Last Dose Of Study Drug'}, {'measure': 'Part B: Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept', 'timeFrame': 'Study Day 1 Through 12 Weeks After Last Dose Of Study Drug'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IgA nephropathy', 'glomerulonephritis, IgA', 'Immunoglobulin A nephropathy', 'Berger disease', 'lupus nephritis', 'lupus glomerulonephritides', 'primary membranous nephropathy', 'membranous nephropathy', 'glomerulonephritis, membranous', 'PLA2R', 'THSD7A', 'ALPN-303', 'povetacicept', 'RUBY-3', 'RUBY3', 'Gd-IgA1', 'GdIgA1', 'anti-neutrophil cytoplasmic antibody associated vasculitis', 'ANCA Vasculitis', 'AAV', 'Microscopic polyangiitis', 'Granulomatosis with polyangiitis', 'Eosinophilic granulomatosis with polyangiitis', "Wegener's granulomatosis", 'Churg-Strauss Disease', 'Myeloperoxidase (MPO)', 'Proteinase 3 (PR3)'], 'conditions': ['Lupus Nephritis', 'Immunoglobulin A Nephropathy', 'Membranous Nephropathy', 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis - LN), or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) to determine if povetacicept is safe and potentially beneficial in treating these diseases.\n\nDuring the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52-week treatment extension period. Participants with IgAN and pMN may also receive povetacicept for an additional 52 weeks, if eligible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria Summary:\n\nPart A:\n\n* Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN)\n* On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1\n* Indication-specific criteria:\n\n 1. IgAN\n\n * Biopsy-confirmed diagnosis less than or equal to (≤)10 years prior to the start of screening AND Screening UPCR greater than or equal to (≥)0.5 g/g.\n * No background immunosuppression therapies.\n 2. pMN\n\n * A historical biopsy-confirmed diagnosis with positive anti-PLA2R1 antibodies or anti-THSD7A antibodies at screening AND Screening UPCR ≥1 g/g\n * Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at least 12 weeks.\n * No background immunosuppression therapies except for optional calcineurin inhibitors.\n 3. LN\n\n * A Biopsy-confirmed diagnosis of active, proliferative Class III, IV, (with or without Class V) LN ≤6 months prior to the start of screening AND Screening UPCR ≥1 g/g,\n * Anti-dsDNA at screening. Anti-dsDNA testing is required but the result need not be positive.\n * On stable background immunosuppression ≥ 8 weeks prior to Day 1\n 4. AAV\n\n * Past diagnosis of renal AAV, defined as either of the following:\n * History of renal biopsy consistent with renal AAV.\n * History of clinically diagnosed renal AAV.\n * Myeloperoxidase (MPO)-ANCA or proteinase 3 (PR3)-ANCA positive by enzyme-linked immunosorbent assay at screening.\n * At least 4 weeks since initiation of AAV induction therapy, if applicable.\n\n Part B:\n* Participants meet at least 1 of the following criteria:\n\n * Completed investigational product (IP) treatment and 24 weeks of follow-up in Part A, or\n * Had IP interruption(s) in Part A, but did not permanently discontinue IP, and completed study visits up to the last scheduled visit of the follow-up period of Part A.\n\nKey Exclusion Criteria Summary:\n\nPart A:\n\n* Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease\n* eGFR \\<30 milliliter per minute per square meter (mL/min/1.73m\\^2) or rapidly progressive glomerulonephritis\n* Recent serious or ongoing infection; risk or history of serious infection\n* Receipt of B cell depleting therapies or anti-BAFF and/or APRIL therapies within protocol specified timeframes\n\nPart B:\n\n* History of poor compliance with IP and/or procedures in Part A, as deemed by the investigator or Sponsor\n* History of any AEs or clinical conditions during Part A or emerging thereafter that may pose a safety concern for participation in Part B as deemed by investigator or Sponsor.\n\nOther protocol defined Inclusion/Exclusion criteria will apply'}, 'identificationModule': {'nctId': 'NCT05732402', 'acronym': 'RUBY-3', 'briefTitle': 'An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alpine Immune Sciences, Inc.'}, 'officialTitle': 'An Open-Label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects With Autoantibody-Associated Glomerular Diseases (RUBY-3)', 'orgStudyIdInfo': {'id': 'AIS-D03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Povetacicept', 'description': 'Part A: Participants will receive povetacicept for 24 weeks with the possibility of participating in treatment extensions through 104 weeks of treatment.\n\nPart B: Participants with IgAN and pMN will receive povetacicept for an additional 52 weeks.', 'interventionNames': ['Drug: Povetacicept']}], 'interventions': [{'name': 'Povetacicept', 'type': 'DRUG', 'otherNames': ['ALPN-303'], 'description': 'Administered by subcutaneous injection every 4 weeks', 'armGroupLabels': ['Povetacicept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site (523)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85302', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site (501)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site (524)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91335', 'city': 'Valencia', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site (506)', 'geoPoint': {'lat': 34.44361, 'lon': -118.60953}}, {'zip': '80002', 'city': 'Arvada', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site (513)', 'geoPoint': {'lat': 39.80276, 'lon': -105.08748}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site (512)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site (525)', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site (502)', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site (503)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site (509)', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '12209', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site (511)', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site (508)', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site (518)', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '76034', 'city': 'Colleyville', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site (118)', 'geoPoint': {'lat': 32.88096, 'lon': -97.15501}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site (516)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75061', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site (526)', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site (519)', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '3021', 'city': 'Saint Albans', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Investigational Site (515)', 'geoPoint': {'lat': -37.73333, 'lon': 144.8}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Investigational Site (102)', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '00725', 'city': 'Caguas', 'country': 'Puerto Rico', 'facility': 'Investigational Site (191)', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}, {'zip': '31151', 'city': 'Cheonan', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Investigational Site (507)', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'zip': '14068', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigational Site (505)', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '10444', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigational Site (504)', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '11923', 'city': 'Guri-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigational Site (510)', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigational Site (125)'}, {'zip': '03181', 'city': 'Seoul', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigational Site (520)'}, {'zip': '05278', 'city': 'Seoul', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigational Site (521)'}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigational Site (116)', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alpine Immune Sciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}