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

NCT06740526 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 417-201-00060
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 5

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.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52

  From Baseline to Week 52

Study Arms (1)

Sibeprenlimab

EXPERIMENTAL

Drug: Sibeprenlimab

Interventions

Sibeprenlimab DRUG

Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)

Sibeprenlimab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
• Source-verified kidney biopsy confirmed diagnosis of IgAN.
• 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)

You may not qualify if:

• Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
• Participant has coexisting chronic kidney disease, other than IgAN.
• Participant has a serum IgG value \<600 mg/dL at screening.
• 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).
• Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
• Participants who would be likely to require prohibited concomitant therapy during the trial.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (5)

Clinical Research Site 330

Denver, Colorado, 80230, United States

RECRUITING

Clinical Research Site 369

Boston, Massachusetts, 21144, United States

RECRUITING

Clinical Research Site 374

Dakota Dunes, South Dakota, 57409, United States

RECRUITING

Clinical Research Site 324

Houston, Texas, 77054, United States

RECRUITING

Clinical Research Site 305

Scarborough Village, Ontario, M1H 3G4, Canada

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Otsuka Call Center

CONTACT

844-687-8522; Otsuka-ProfessionalServices@otsuka-us.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): April 17, 2029
• Study Completion (Estimated): April 17, 2029
• Last Updated: April 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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

Locations

US (4); CA (1)