Open-Label Extension Study of BION-1301 in IgA Nephropathy

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label extension (OLE) study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of BION-1301 in adults with IgA nephropathy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinook Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Participated in Study ADU-CL-19 and received at least 5 of 7 doses if enrolled in Cohort 1 (dosed once every 2 weeks) and 3 of 4 doses if enrolled in Cohort 2 (dosed once every 4 weeks).

• Male or female ≥18 years old at Screening

• Males must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through 10 weeks after the final dose of study drug)

• Women of child-bearing potential (WOCBP) must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through 10 weeks after the final dose of study drug)

• Able to provide signed informed consent

Exclusion Criteria:

• Received systemic corticosteroid therapy (> 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 3 months prior to the first dose of study drug

• Female who is breastfeeding

• Type 1 or 2 diabetes

• Current malignancy or history of malignancy during the last 3 years

• Known or suspected allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody