Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07770815
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Sibeprenlimab — DRUG
    Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose
  • Standard of care — DRUG
    Standard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs)

Study Details

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).

Key Dates

First listed
Aug 18, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 29, 2029
Completion
Feb 23, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sibeprenlimab
    Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks as an add-on to standard of care treatment at a weight-based dose.

Primary Outcome Measure

Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples [ Time Frame: Baseline, Week 40 ]

Central Contacts

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