Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy

This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.

Study Overview

• Status: Recruiting
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: Sibeprenlimab

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Otsuka Call Center; Phone Number: 844-687-8522; Email: Otsuka-ProfessionalServices@otsuka-us.com

Study Locations

• Canada
  • Ontario
    • Scarborough, Ontario, Canada, M1H 3G4
      • Recruiting
      • Clinical Research Site 305
      • Contact: Otsuka Call Center
• United States
  • Colorado
    • Denver, Colorado, United States, 80230
      • Recruiting
      • Clinical Research Site 330
      • Contact: Otsuka Call Center
  • Massachusetts
    • Boston, Massachusetts, United States, 21144
      • Recruiting
      • Clinical Research Site 369
      • Contact: Otsuka Call Center
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57409
      • Recruiting
      • Clinical Research Site 374
      • Contact: Otsuka Call Center
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • Clinical Research Site 324
      • Contact: Otsuka Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
2. Source-verified kidney biopsy confirmed diagnosis of IgAN.
3. Participant has estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration [CKD EPI] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 [CKiD U25] eGFR equation for those younger than 18 years)

Exclusion Criteria:

1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
2. Participant has coexisting chronic kidney disease, other than IgAN.
3. Participant has a serum IgG value <600 mg/dL at screening.

4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:

   topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).

5. Participant has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).
6. Participants who would be likely to require prohibited concomitant therapy during the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sibeprenlimab	Drug: Sibeprenlimab; Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52	From Baseline to Week 52

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Estimated): April 17, 2029
• Study Completion (Estimated): April 17, 2029

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: 417-201-00060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No