A Phase 1/2 interventional study of Povetacicept in Lupus Nephritis, Immunoglobulin A Nephropathy and Membranous Nephropathy, sponsored by Alpine Immune Sciences, Inc.. Active, not recruiting at 30 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Alpine Immune Sciences, Inc. (part of Vertex Pharmaceuticals Incorporated) · Phase 1/2, Interventional, and Treatment
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.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's enrollment of 72 is above the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Alpine Immune Sciences, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
First submitted before Alpine Immune Sciences, Inc. became part of Vertex Pharmaceuticals Incorporated.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria Summary:
Part A:
Indication-specific criteria:
IgAN
pMN
LN
AAV
Part B:
Participants meet at least 1 of the following criteria:
Key Exclusion Criteria Summary:
Part A:
Part B:
Other protocol defined Inclusion/Exclusion criteria will apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Povetacicept
Administered by subcutaneous injection every 4 weeks
Also known as: ALPN-303
Part A: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
Part A: Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept
Time frame: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept
Time frame: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
Part A: Time Required for Povetacicept To Reach Half its Concentration (t1/2)
Time frame: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Time Required for Povetacicept To Reach Half its Concentration (t1/2)
Time frame: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
Part A: Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE).
Time frame: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE)
Time frame: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
Part A: Change from Baseline in Peripheral Blood Lymphocytes and Subsets
Time frame: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Change from Baseline in Peripheral Blood Lymphocytes and Subsets
Time frame: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
Part A:Change from Baseline Over Time In Circulating Levels Of anti-dsDNA in LN; galactose deficient IgA1 (Gd-IgA1) and anti-Gd-IgA1 in IgAN; anti-PLA2R1 or anti THSD7A in pMN and anti-PR3 or anti-MPO in AAV
Time frame: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Change from Baseline Over Time In Circulating Levels Of galactose deficient IgA1 (Gd-IgA1) and anti-Gd-IgA1 in IgAN; anti-PLA2R1 or anti THSD7A in pMN
Time frame: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
Part A: Change From Baseline Over Time In Complement Components (C3, C4, CH50)
Time frame: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Change From Baseline Over Time In Complement Components (C3, C4, CH50)
Time frame: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
Part A: Immunological Remission (pMN only)
Time frame: Study Day 1 Through Week 24 After Dose of Study Drug
Part B: Immunological Remission (pMN only)
Time frame: Study Day 1 Through Week 12 After Dose of Study Drug
Part A: Change from Baseline at Week 24 in UPCR (Urine protein/creatinine ratio) (based on assessment of 24-hour urine)
Time frame: Baseline and at Week 24
Part A: Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and at Week 24
Part B: Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and at Week 24
Part A: Renal Response
Time frame: At Week 24
Part A: Remission of Vasculitis (Birmingham Vasculitis Activity Score (BVAS = 0)) (for AAV cohorts only)
Time frame: At Week 24
Part A: Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept
Time frame: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept
Time frame: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
Plan to share: No — Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Povetacicept
Alpine Immune Sciences, Inc. →