IgA Nephropathy
Conditions
Brief summary
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).
Interventions
DRUGSibeprenlimab
Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose
DRUGStandard of care
Standard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs)
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Source-verified, biopsy-confirmed IgA nephropathy (IgAN). 2. 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. 3. 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. 4. 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). 5. Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2). 6. No evidence of coexisting chronic kidney disease other than IgAN. 7. Serum immunoglobulin G (IgG) ≥ 600 mg/dL at screening. 8. Kidney biopsy findings not demonstrating additional pathological features inconsistent with IgAN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples | Baseline, Week 40 |
| Serum Concentration of Sibeprenlimab Through Week 52 | Baseline through Week 52 |
| Change From Baseline in Serum Immunoglobulin A (IgA) Through Week 52 | Baseline through Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Study Discontinuations Due to Adverse Events Through Week 60 | Baseline through Week 60 | — |
| Number of Participants With Clinically Significant Changes in Vital Signs Through Week 60 | Baseline through Week 60 | — |
| Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 60 | Baseline through Week 60 | — |
| Number of Participants With Clinically Significant Changes in Laboratory Assessments Through Week 60 | Baseline through Week 60 | Laboratory assessments include hematology, serum chemistry, and urine laboratory parameters. |
| Number of Injection Site Reactions Through Week 52 | Baseline through Week 52 | — |
| Number of Participants With Anti-Drug Antibody (ADA) From Baseline Through Week 60 | Baseline through Week 60 | — |
Contacts
CONTACTOtsuka Call Center
Outcome results
None listed