RUBY-3: An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases

Sponsor

Alpine Immune Sciences, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05732402

Collaborator

(none)

Enrollment

Arms

34.1

Anticipated Duration (Months)

Study Details

Study Description

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, 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.

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis Immunoglobulin A Nephropathy Membranous Nephropathy	Drug: povetacicept Drug: povetacicept	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: povetacicept 80mg	Drug: povetacicept Administered by subcutaneous injection every 4 weeks Other Names: ALPN-303
Experimental: povetacicept 240mg	Drug: povetacicept Administered by subcutaneous injection every 4 weeks Other Names: ALPN-303

Arm

Intervention/Treatment

Experimental: povetacicept 80mg

Drug: povetacicept

Administered by subcutaneous injection every 4 weeks

Other Names:

ALPN-303

Experimental: povetacicept 240mg

Drug: povetacicept

Administered by subcutaneous injection every 4 weeks

Other Names:

ALPN-303

Outcome Measures

Primary Outcome Measures

Adverse Events [Study Day 1 through 30 days after last dose of study drug]
Type, incidence, severity, and seriousness of AEs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria Summary:

Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN)
Indication-specific criteria:
IgAN

UPCR ≥0.5 g/g

Less than 50% reduction of proteinuria in the last 24 weeks while on angiotensin converting enzyme inhibitor (ACEis)/angiotensin II receptor blockers (ARBs)
UPCR ≥3.5 g/g
Positive anti-PLA2R1 antibodies or anti-THSD7A antibodies

UPCR ≥1 g/g, with additional criteria per protocol
Positive anti-dsDNA
Positive anti-nuclear antibody

On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1
Receiving stable dose(s) of standard-of-care medications and no prohibited concomitant medications per protocol