Recruiting
Phase 2

Sibeprenlimab

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Code:

NCT06740526

Conditions

IgA Nephropathy

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Sibeprenlimab

Study Details

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

Study ID

NCT06740526

Start date

Nov 19, 2024

Status verified date

Dec, 2024

Completion date

Apr 17, 2029

Anticipated

Primary completion date

Apr 17, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sibeprenlimab

Interventions

Sibeprenlimab

Sibeprelimab SC (Period 1)

Sibeprelimab SC (Period 2)

Primary outcome measure

  • Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52 [ Time Frame: From Baseline to Week 52 ]

Central Contacts and Locations

Locations

Clinical Research Site 330

Recruiting

Denver, Colorado, United States, 80230

Clinical Research Site 369

Recruiting

Boston, Massachusetts, United States, 21144

Clinical Research Site 374

Recruiting

Dakota Dunes, South Dakota, United States, 57409

Clinical Research Site 324

Recruiting

Houston, Texas, United States, 77054

Clinical Research Site 305

Recruiting

Scarborough, Ontario, Canada, M1H 3G4

More Information

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Last update posted

Apr 6, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc. on 2025-04-06.