An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05732402
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Alpine Immune Sciences, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jiahua Li, M.D.
Principal Investigator Affiliation	Alpine Immune Sciences, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Korea, Republic of, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Nephritis, Immunoglobulin A Nephropathy, Membranous Nephropathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Arms & Interventions

Arms

Experimental: povetacicept 80mg

Experimental: povetacicept 240mg

Interventions

Drug: - povetacicept

Administered by subcutaneous injection every 4 weeks

Drug: - povetacicept

Administered by subcutaneous injection every 4 weeks

Contact a Trial Team

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Investigational Site (523), Phoenix, Arizona

Status

Recruiting

Address

Investigational Site (523)

Phoenix, Arizona, 85016

Site Contact

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