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, or lupus-related kidney disease (lupus nephritis) 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 study 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 OR.
  • - Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at lease 12 weeks.
  • - No background immunosuppression therapies except for optional calcineurin inhibitors.
3. 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, OR additional criteria per protocol criteria per protocol.
  • - Positive anti-dsDNA at screening.
  • - Positive anti-nuclear antibody.
  • - 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

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigational Site (523), Phoenix, Arizona

Status

Recruiting

Address

Investigational Site (523)

Phoenix, Arizona, 85016

Investigational Site (501), Phoenix, Arizona

Status

Recruiting

Address

Investigational Site (501)

Phoenix, Arizona, 85302

Investigational Site (524), Tucson, Arizona

Status

Recruiting

Address

Investigational Site (524)

Tucson, Arizona, 85712

Investigational Site (506), Valencia, California

Status

Recruiting

Address

Investigational Site (506)

Valencia, California, 91335

Investigational Site (513), Arvada, Colorado

Status

Recruiting

Address

Investigational Site (513)

Arvada, Colorado, 80002

Investigational Site (512), Orlando, Florida

Status

Recruiting

Address

Investigational Site (512)

Orlando, Florida, 32806

Investigational Site (502), Lawrenceville, Georgia

Status

Recruiting

Address

Investigational Site (502)

Lawrenceville, Georgia, 30046

Investigational Site (503), Boston, Massachusetts

Status

Recruiting

Address

Investigational Site (503)

Boston, Massachusetts, 02115

Investigational Site (509), Newark, New Jersey

Status

Recruiting

Address

Investigational Site (509)

Newark, New Jersey, 07103

Investigational Site (511), Albany, New York

Status

Recruiting

Address

Investigational Site (511)

Albany, New York, 12209

Investigational Site (508), Brooklyn, New York

Status

Recruiting

Address

Investigational Site (508)

Brooklyn, New York, 11203

Investigational Site (518), Bethlehem, Pennsylvania

Status

Recruiting

Address

Investigational Site (518)

Bethlehem, Pennsylvania, 18017

Investigational Site (516), Houston, Texas

Status

Recruiting

Address

Investigational Site (516)

Houston, Texas, 77054

International Sites

Investigational Site (519), Concord, New South Wales, Australia

Status

Recruiting

Address

Investigational Site (519)

Concord, New South Wales, 2139

Investigational Site (515), Saint Albans, Victoria, Australia

Status

Recruiting

Address

Investigational Site (515)

Saint Albans, Victoria, 3021

Investigational Site (102), Nedlands, Western Australia, Australia

Status

Recruiting

Address

Investigational Site (102)

Nedlands, Western Australia, 6009

Investigational Site (507), Cheonan, Chungcheongnam-do, Korea, Republic of

Status

Recruiting

Address

Investigational Site (507)

Cheonan, Chungcheongnam-do, 31151

Investigational Site (505), Anyang-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Investigational Site (505)

Anyang-si, Gyeonggi-do, 14068

Investigational Site (504), Goyang-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Investigational Site (504)

Goyang-si, Gyeonggi-do, 10444

Investigational Site (510), Guri-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Investigational Site (510)

Guri-si, Gyeonggi-do, 11923

Investigational Site (125), Seoul, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Investigational Site (125)

Seoul, Gyeonggi-do, 03080

Investigational Site (520), Seoul, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Investigational Site (520)

Seoul, Gyeonggi-do, 03181

Investigational Site (521), Seoul, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Investigational Site (521)

Seoul, Gyeonggi-do, 05278

Investigational Site (116), Suwon-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Investigational Site (116)

Suwon-si, Gyeonggi-do, 16499