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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
19/07/2024

Titles & IDs
Public title
An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney 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
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
Study Day 1 through 90 days 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:

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
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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
1/01/2026
Actual
Sample size
Target
56
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
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Chungcheongnam-do
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Gyeonggi-do
Country [13] 0 0
Puerto Rico
State/province [13] 0 0
Caguas

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05732402
Trial related presentations / publications
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Murphy
Address 0 0
Country 0 0
Phone 0 0
919-786-8898
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05732402