A Study of BION-1301 in Adults With IgA Nephropathy

• Status: Not yet recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinook Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.

• Biopsy-proven IgAN within the past 10 years that is not due to secondary causes. A pseudonymized copy of the report must be available for review. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Medical Monitor.

• eGFR ≥ 30 mL/min/1.73m2 at Screening based on the 2021 CKD-EPI equation (for the exploratory cohort only: eGFR of ≥20 to < 30 mL/min/1.73 m2).

• Total urine protein ≥ 1.0 g/day and UPCR ≥ 0.7 g/g, as measured from an adequate 24hour urine collection at Screening by a central laboratory.

• Stable on a maximally tolerated dose of ACEi/ARB for at least 12 weeks prior to Screening or intolerant to ACEi/ARB; may also be on a stable and well tolerated dose of SGLT2i and/or ERAs/MRAs for at least 12 weeks prior to Screening for the treatment of IgAN.

• Body mass index (BMI) between 18 and 40 kg/m2.

• Screening weight of at least 50 kg.

• Men and women of childbearing potential must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives after the final dose of study drug. Provide written informed consent and be willing to comply with study visits and procedures.

Exclusion Criteria:

• Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.

• Diagnosis of IgA Vasculitis or current or history of nephrotic syndrome

• Average blood pressure (BP) > 150/90 mm Hg (systolic/diastolic). Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines (KDIGO, 2021)

• Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN.

• History of Type 1 Diabetes.

• Subjects with Type 2 diabetes are excluded if any of the following are present:

• Screening HbA1c of > 8%.

• Evidence of diabetic changes on kidney biopsy, performed for any reason.

• History of diabetic microvascular/macrovascular disease. Unstable anti-diabetic regimen

• Prior exposure to any antibody directed against APRIL.

• History of a previous severe allergic reaction including a history of severe hypersensitivity reaction to any monoclonal antibody.

• Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening.

• Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for >14 days within 12 weeks prior to Screening.

• Use of systemic immunosuppressant medications

• Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator.

• Positive serology test for HIV or hepatitis infection.

• Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug.

• Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.

• Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.