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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05732402
Registration number
NCT05732402
Ethics application status
Date submitted
8/02/2023
Date registered
17/02/2023
Date last updated
15/06/2025
Titles & IDs
Public title
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
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Scientific title
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)
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Secondary ID [1]
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AIS-D03
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Universal Trial Number (UTN)
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Trial acronym
RUBY-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis
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Immunoglobulin A Nephropathy
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Membranous Nephropathy
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Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Inflammatory and Immune System
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Autoimmune diseases
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Povetacicept
Experimental: Povetacicept - Participants will receive Povetacicept for 24 weeks with the possibility of participating in treatment extensions through 104 weeks of treatment.
Treatment: Drugs: Povetacicept
Administered by subcutaneous injection every 4 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Timepoint [1]
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Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
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Secondary outcome [1]
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Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept
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Assessment method [1]
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Timepoint [1]
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Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
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Secondary outcome [2]
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Time Required for Povetacicept To Reach Half its Concentration (t1/2)
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Assessment method [2]
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Timepoint [2]
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Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
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Secondary outcome [3]
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Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE).
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Assessment method [3]
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Timepoint [3]
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Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
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Secondary outcome [4]
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Change from Baseline in Peripheral Blood Lymphocytes and Subsets
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Assessment method [4]
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Timepoint [4]
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Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
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Secondary outcome [5]
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Change from Baseline Over Time In Circulating Levels Of anti-dsDNA in LN; galactose deficient IgA1 (Gd-IgA1); anti-PLA2R1 or anti THSD7A in pMN and anti-PR3 or anti-MPO in Anti-neutrophil Cytoplasmic Antibody Associated Vasculitis (AAV)
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Assessment method [5]
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Timepoint [5]
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Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
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Secondary outcome [6]
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Change From Baseline Over Time In Complement Components (C3, C4, CH50)
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Assessment method [6]
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Timepoint [6]
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Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
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Secondary outcome [7]
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Immunological Remission
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Assessment method [7]
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Timepoint [7]
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At 12, 24, 36, 48, and 52 Weeks
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Secondary outcome [8]
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Change from Baseline at Week 24 in UPCR(Urine protein/creatinine ratio) (based on assessment of 24-hour urine)
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Assessment method [8]
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Timepoint [8]
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Baseline and at Week 24
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Secondary outcome [9]
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Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)
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Assessment method [9]
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Timepoint [9]
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Baseline and at Week 24
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Secondary outcome [10]
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Renal Response
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Assessment method [10]
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Timepoint [10]
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At Week 24
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Secondary outcome [11]
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Remission of Vasculitis (Birmingham Vasculitis Activity Score (BVAS = 0)) (for AAV cohorts only)
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Assessment method [11]
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Timepoint [11]
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At Week 24
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Secondary outcome [12]
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Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept
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Assessment method [12]
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Timepoint [12]
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Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
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Eligibility
Key inclusion criteria
Key Inclusion Criteria Summary:
1. Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN) 2.
Indication-specific criteria:
a. IgAN
* 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.
* No background immunosuppression therapies.
pMN
* A historical biopsy-confirmed diagnosis with positive anti-PLA2R1 antibodies or anti-THSD7A antibodies at screening AND Screening UPCR =1 g/g
* Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at least 12 weeks.
* No background immunosuppression therapies except for optional calcineurin inhibitors.
LN
* 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,
* Positive anti-dsDNA at screening
* On stable background immunosuppression = 8 weeks prior to Day 1
AAV
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Past diagnosis of renal AAV, defined as either of the following:
* History of renal biopsy consistent with renal AAV.
* History of clinically diagnosed renal AAV.
* Myeloperoxidase (MPO)-ANCA or proteinase 3 (PR3)-ANCA positive by enzyme-linked immunosorbent assay at screening.
* At least 4 weeks since initiation of AAV induction therapy, if applicable.
3. On maximal dose or the maximally tolerated dose ACEis/ARBs for =12 weeks prior to study Day 1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria Summary:
1. Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease
2. eGFR <30 (milliliter per minute per square meter (mL/min/1.73m^2) or rapidly progressive glomerulonephritis
3. Recent serious or ongoing infection; risk or history of serious infection
4. Receipt of B cell depleting therapies or anti-BAFFand/or APRIL therapies within protocol specified timeframes
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/01/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
72
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Investigational Site (519) - Concord
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Recruitment hospital [2]
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Investigational Site (515) - Saint Albans
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Recruitment hospital [3]
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Investigational Site (102) - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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3021 - Saint Albans
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Colorado
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Georgia
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Country [6]
0
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United States of America
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State/province [6]
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Maryland
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Country [7]
0
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United States of America
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State/province [7]
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Massachusetts
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Country [8]
0
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United States of America
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State/province [8]
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Missouri
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Country [9]
0
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United States of America
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State/province [9]
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New Jersey
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Country [10]
0
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United States of America
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State/province [10]
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New York
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Country [11]
0
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United States of America
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State/province [11]
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Pennsylvania
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Country [12]
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United States of America
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State/province [12]
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Texas
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Country [13]
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Korea, Republic of
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State/province [13]
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Chungcheongnam-do
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Country [14]
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Korea, Republic of
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State/province [14]
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Gyeonggi-do
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Country [15]
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Puerto Rico
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State/province [15]
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Caguas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alpine Immune Sciences, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy, membranous nephropathy, lupus-related kidney disease (lupus nephritis). or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis to determine if povetacicept is safe and potentially beneficial in treating these diseases. During 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 .
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Trial website
https://clinicaltrials.gov/study/NCT05732402
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jiahua Li, M.D.
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Address
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Alpine Immune Sciences, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Medical Information
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Address
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Country
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Phone
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617-341-6777
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Fax
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Email
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medicalinfo@vrtx.com
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05732402
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