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

Phase 2

Recruiting

• Conditions: IgA Nephropathy
• Interventions: Drug: Sibeprenlimab

• Registration Number: NCT06740526
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2029-04-17
• Study Completion: 2029-04-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sibeprenlimab	Sibeprenlimab	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52	From Baseline to Week 52

Trial Locations

Locations (5)

Clinical Research Site 330; 🇺🇸 Denver, Colorado, United States

Clinical Research Site 369; 🇺🇸 Boston, Massachusetts, United States

Clinical Research Site 374; 🇺🇸 Dakota Dunes, South Dakota, United States

Clinical Research Site 324; 🇺🇸 Houston, Texas, United States

Clinical Research Site 305; 🇨🇦 Scarborough, Ontario, Canada