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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

Titles & IDs
Public title
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
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)
Secondary ID [1] 0 0
AIS-D03
Universal Trial Number (UTN)
Trial acronym
RUBY-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Immunoglobulin A Nephropathy 0 0
Membranous Nephropathy 0 0
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assessment method [1] 0 0
Timepoint [1] 0 0
Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Secondary outcome [1] 0 0
Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept
Assessment method [1] 0 0
Timepoint [1] 0 0
Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Secondary outcome [2] 0 0
Time Required for Povetacicept To Reach Half its Concentration (t1/2)
Assessment method [2] 0 0
Timepoint [2] 0 0
Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Secondary outcome [3] 0 0
Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE).
Assessment method [3] 0 0
Timepoint [3] 0 0
Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Secondary outcome [4] 0 0
Change from Baseline in Peripheral Blood Lymphocytes and Subsets
Assessment method [4] 0 0
Timepoint [4] 0 0
Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Secondary outcome [5] 0 0
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)
Assessment method [5] 0 0
Timepoint [5] 0 0
Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Secondary outcome [6] 0 0
Change From Baseline Over Time In Complement Components (C3, C4, CH50)
Assessment method [6] 0 0
Timepoint [6] 0 0
Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Secondary outcome [7] 0 0
Immunological Remission
Assessment method [7] 0 0
Timepoint [7] 0 0
At 12, 24, 36, 48, and 52 Weeks
Secondary outcome [8] 0 0
Change from Baseline at Week 24 in UPCR(Urine protein/creatinine ratio) (based on assessment of 24-hour urine)
Assessment method [8] 0 0
Timepoint [8] 0 0
Baseline and at Week 24
Secondary outcome [9] 0 0
Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)
Assessment method [9] 0 0
Timepoint [9] 0 0
Baseline and at Week 24
Secondary outcome [10] 0 0
Renal Response
Assessment method [10] 0 0
Timepoint [10] 0 0
At Week 24
Secondary outcome [11] 0 0
Remission of Vasculitis (Birmingham Vasculitis Activity Score (BVAS = 0)) (for AAV cohorts only)
Assessment method [11] 0 0
Timepoint [11] 0 0
At Week 24
Secondary outcome [12] 0 0
Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept
Assessment method [12] 0 0
Timepoint [12] 0 0
Study Day 1 Through 24 Weeks After Last Dose Of Study Drug

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

•

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
296
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site (519) - Concord
Recruitment hospital [2] 0 0
Investigational Site (515) - Saint Albans
Recruitment hospital [3] 0 0
Investigational Site (102) - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
3021 - Saint Albans
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Chungcheongnam-do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Gyeonggi-do
Country [15] 0 0
Puerto Rico
State/province [15] 0 0
Caguas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alpine Immune Sciences, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Jiahua Li, M.D.
Address 0 0
Alpine Immune Sciences, Inc.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Information
Address 0 0
Country 0 0
Phone 0 0
617-341-6777
Email 0 0
medicalinfo@vrtx.com
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