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)

Status: Active_not_recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis - LN), or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) 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. Participants with IgAN and pMN may also receive povetacicept for an additional 52 weeks, if eligible.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ Part A:

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

• On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1

• Indication-specific criteria:

∙ 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,

• Anti-dsDNA at screening. Anti-dsDNA testing is required but the result need not be positive.

• 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.

∙ Part B:

• Participants meet at least 1 of the following criteria:

‣ Completed investigational product (IP) treatment and 24 weeks of follow-up in Part A, or

⁃ Had IP interruption(s) in Part A, but did not permanently discontinue IP, and completed study visits up to the last scheduled visit of the follow-up period of Part A.

Locations
United States
Arizona
Investigational Site (501)
Phoenix
Investigational Site (523)
Phoenix
Investigational Site (524)
Tucson
California
Investigational Site (506)
Valencia
Colorado
Investigational Site (513)
Arvada
Florida
Investigational Site (512)
Orlando
Investigational Site (525)
Tamarac
Georgia
Investigational Site (502)
Lawrenceville
Massachusetts
Investigational Site (503)
Boston
Maryland
The Johns Hopkins University School of Medicine
Baltimore
Missouri
Washington University School of Medicine in St. Louis
St Louis
New Jersey
Investigational Site (509)
Newark
New York
Investigational Site (511)
Albany
Investigational Site (508)
Brooklyn
Pennsylvania
Investigational Site (518)
Bethlehem
Texas
Investigational Site (118)
Colleyville
Investigational Site (516)
Houston
Investigational Site (526)
Irving
Other Locations
Australia
Investigational Site (519)
Concord
Investigational Site (102)
Nedlands
Investigational Site (515)
Saint Albans
Puerto Rico
Investigational Site (191)
Caguas
Republic of Korea
Investigational Site (505)
Anyang-si
Investigational Site (507)
Cheonan
Investigational Site (504)
Goyang-si
Investigational Site (510)
Guri-si
Investigational Site (125)
Seoul
Investigational Site (520)
Seoul
Investigational Site (521)
Seoul
Investigational Site (116)
Suwon
Time Frame
Start Date: 2023-03-15
Completion Date: 2028-03-02
Participants
Target number of participants: 72
Treatments
Experimental: Povetacicept
Part A: Participants will receive povetacicept for 24 weeks with the possibility of participating in treatment extensions through 104 weeks of treatment.~Part B: Participants with IgAN and pMN will receive povetacicept for an additional 52 weeks.
Sponsors
Leads: Alpine Immune Sciences, Inc.

This content was sourced from clinicaltrials.gov