To navigate the following site navigation expect to utilize the tab key to move through items sequentially. The spacebar or enter keys can be utilized to interact with items that open sub-navigation.
When autocomplete results are available use up and down arrows to review and enter to select.
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,
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 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.
- 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
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.
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.
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.