Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05732402
Registration number
NCT05732402
Ethics application status
Date submitted
8/02/2023
Date registered
17/02/2023
Date last updated
4/06/2024
Titles & IDs
Public title
An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases
Query!
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)
Query!
Secondary ID [1]
0
0
AIS-D03
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RUBY-3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis
0
0
Query!
Immunoglobulin A Nephropathy
0
0
Query!
Membranous Nephropathy
0
0
Query!
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - povetacicept
Treatment: Drugs - povetacicept
Experimental: povetacicept 80mg -
Experimental: povetacicept 240mg -
Treatment: Drugs: povetacicept
Administered by subcutaneous injection every 4 weeks
Treatment: Drugs: povetacicept
Administered by subcutaneous injection every 4 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Adverse Events
Query!
Assessment method [1]
0
0
Type, incidence, severity, and seriousness of AEs
Query!
Timepoint [1]
0
0
Study Day 1 through 90 days after last dose of study drug
Query!
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:
1. IgAN
- Biopsy-confirmed diagnosis =10 years prior to the start of screening AND
Screening UPCR =0.5 g/g.
- No background immunosuppression therapies.
2. 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion Criteria Summary:
1. Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease
2. eGFR <30 mL/min/1.73m2 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-BAFF/APRIL therapies within protocol
specified timeframes
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1/Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/03/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/01/2026
Query!
Actual
Query!
Sample size
Target
56
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
Investigational Site (519) - Concord
Query!
Recruitment hospital [2]
0
0
Investigational Site (515) - Saint Albans
Query!
Recruitment hospital [3]
0
0
Investigational Site (102) - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
3021 - Saint Albans
Query!
Recruitment postcode(s) [3]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Vienna
Query!
Country [12]
0
0
Korea, Republic of
Query!
State/province [12]
0
0
Chungcheongnam-do
Query!
Country [13]
0
0
Korea, Republic of
Query!
State/province [13]
0
0
Gyeonggi-do
Query!
Country [14]
0
0
Norway
Query!
State/province [14]
0
0
Trondelag
Query!
Country [15]
0
0
Norway
Query!
State/province [15]
0
0
Sarpsborg
Query!
Country [16]
0
0
Spain
Query!
State/province [16]
0
0
Community Of Catalonia
Query!
Country [17]
0
0
United Kingdom
Query!
State/province [17]
0
0
England
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Alpine Immune Sciences, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The goal of this clinical study is to evaluate multiple dose levels of povetacicept
(ALPN-303) 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05732402
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Jiahua Li, M.D.
Query!
Address
0
0
Alpine Immune Sciences, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Sarah Murphy
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
919-786-8898
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05732402
Download to PDF