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Evaluating Povetacicept for Autoantibody-Associated Kidney Diseases

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)

Phase1; Phase2 Interventional Alpine Immune Sciences, Inc. · NCT05732402

This study is testing a new treatment called povetacicept to see if it can help adults with certain kidney diseases linked to autoantibodies feel better and manage their condition.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment296 (estimated)
Ages18 Years and up
SexAll
SponsorAlpine Immune Sciences, Inc. Industry-sponsored
Locations30 sites (Phoenix, Arizona and 29 other locations)
Trial IDNCT05732402 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety and efficacy of povetacicept in adults diagnosed with various autoantibody-associated glomerular diseases, including lupus nephritis, immunoglobulin A nephropathy, and membranous nephropathy. Participants will receive povetacicept every four weeks for six months, with the option for extended treatment. The study will evaluate multiple dose levels to determine the potential benefits of this treatment in managing these kidney diseases.

Who should consider this trial

Good fit: Ideal candidates include adults with biopsy-confirmed diagnoses of immunoglobulin A nephropathy, membranous nephropathy, or lupus nephritis.

Not a fit: Patients with other forms of kidney disease or those currently receiving immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from serious kidney diseases linked to autoantibodies.

How similar studies have performed: Other studies have shown promise in treating similar conditions with novel therapies, suggesting potential for success with this approach.

Eligibility criteria

Show full 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:

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 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

Where this trial is running

Phoenix, Arizona and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus NephritisImmunoglobulin A NephropathyMembranous NephropathyAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisIgA nephropathyglomerulonephritis, IgAImmunoglobulin A nephropathyBerger disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.