This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric participants aged 2 to 17 years with IgA nephropathy (IgAN). Sibeprenlimab will be administered as an add-on to standard of care therapy consisting of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs).
Source-verified, biopsy-confirmed IgA nephropathy (IgAN).
Receiving a stable and maximally tolerated dose of authorized angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) for at least 12 weeks.
Participants receiving a stable dose of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy for IgAN, if available, in addition to ACEIs and/or ARBs, must have initiated SGLT2i treatment for at least 12 weeks.
Participants must have a urine protein/creatinine ratio (uPCR) ≥ 0.75 grams per gram (g/g), as measured from the geometric mean of 3 first void spot urine samples (collected within the screening window prior to Dose 1).
None
Single group
Sibeprenlimab
DrugSibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose
Standard of care
DrugStandard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs)
Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples
Serum Concentration of Sibeprenlimab Through Week 52
Change From Baseline in Serum Immunoglobulin A (IgA) Through Week 52
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Study Discontinuations Due to Adverse Events Through Week 60
Number of Participants With Clinically Significant Changes in Vital Signs Through Week 60
Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 60
Number of Participants With Clinically Significant Changes in Laboratory Assessments Through Week 60
Laboratory assessments include hematology, serum chemistry, and urine laboratory parameters.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
