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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05732402
Other study ID # AIS-D03
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 15, 2023
Est. completion date January 2026

Study information

Verified date May 2024
Source Alpine Immune Sciences, Inc.
Contact Sarah Murphy
Phone 919-786-8898
Email sarah.murphy@iconplc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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, 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 information / eligibility

Status Recruiting
Enrollment 56
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
povetacicept
Administered by subcutaneous injection every 4 weeks
povetacicept
Administered by subcutaneous injection every 4 weeks

Locations

Country Name City State
Australia Investigational Site (519) Concord New South Wales
Australia Investigational Site (102) Nedlands Western Australia
Australia Investigational Site (515) Saint Albans Victoria
Austria Investigational Site (434) Vienna
Korea, Republic of Investigational Site (505) Anyang-si Gyeonggi-do
Korea, Republic of Investigational Site (507) Cheonan Chungcheongnam-do
Korea, Republic of Investigational Site (504) Goyang-si Gyeonggi-do
Korea, Republic of Investigational Site (510) Guri-si Gyeonggi-do
Korea, Republic of Investigational Site (125) Seoul Gyeonggi-do
Korea, Republic of Investigational Site (520) Seoul Gyeonggi-do
Korea, Republic of Investigational Site (521) Seoul Gyeonggi-do
Korea, Republic of Investigational Site (116) Suwon-si Gyeonggi-do
Norway Investigational Site (433) Sarpsborg
Norway Investigational Site (437) Trondheim Trondelag
Spain Investigational Site (436) Barcelona Community Of Catalonia
United Kingdom Investigational Site (439) London England
United States Investigational Site (511) Albany New York
United States Investigational Site (513) Arvada Colorado
United States Investigational Site (518) Bethlehem Pennsylvania
United States Investigational Site (503) Boston Massachusetts
United States Investigational Site (508) Brooklyn New York
United States Investigational Site (516) Houston Texas
United States Investigational Site (502) Lawrenceville Georgia
United States Investigational Site (509) Newark New Jersey
United States Investigational Site (512) Orlando Florida
United States Investigational Site (501) Phoenix Arizona
United States Investigational Site (523) Phoenix Arizona
United States Investigational Site (525) Tamarac Florida
United States Investigational Site (524) Tucson Arizona
United States Investigational Site (506) Valencia California

Sponsors (1)

Lead Sponsor Collaborator
Alpine Immune Sciences, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Korea, Republic of,  Norway,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Type, incidence, severity, and seriousness of AEs Study Day 1 through 90 days after last dose of study drug
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