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

IgA Nephropathy Clinical Trial

Official title:

A Multicenter, Open-Label Extension (OLE) Study for Patients With Immunoglobulin A Nephropathy (IgAN) Who Participated in A Prior Clinical Study of BION-1301

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684745
• Other study ID #: ADU-CL-24
• Status: Recruiting
• Phase: Phase 2
• Start date: September 10, 2020
• Est. completion date: November 2023

Study information

• Verified date: December 2020
• Source: Chinook Therapeutics, Inc.
• Contact: Chinook Therapeutics
• Phone: (206) 485-7051
• Email: clinicaltrials[@]chinooktx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This is a Phase 2, multicenter, open-label extension (OLE) study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. Patients who previously participated in Study ADU-CL-19 (NCT03945318) will receive open-label treatment with BION-1301 for up to approximately 2 years. Study participants will receive BION-1301 at the same dose, route, and dosing schedule as they received in ADU-CL-19. Dose, route, and/or dosing schedule may be changed during the OLE study based on a review by the Safety Review Team of all available PK, PD, and clinical activity data from previous and ongoing studies of BION-1301.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• BION-1301
A solution for IV infusion administered as multiple doses

Locations

Country	Name	City	State
United States	Amicis Research Center	Northridge	California

Sponsors (1)

Lead Sponsor	Collaborator
Chinook Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the preliminary clinical activity of BION-1301 in patients with IgAN	Changes from baseline in estimated glomerular filtration rate (eGFR), urinary protein/creatinine ratio (UPCR), urinary albumin/creatinine ratio (UACR), and corresponding urinary protein, albumin, and creatinine levels	From enrollment until end of treatment, up to approximately 2 years
Primary	Number of subjects with treatment-emergent adverse events (TEAEs) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)	Number of subjects reporting TEAEs	From enrollment until end of treatment, up to approximately 2 years
Primary	Number of subjects with serious adverse events (SAEs) as assessed by NCI-CTCAE	Number of subjects reporting SAEs	From enrollment until end of treatment, up to approximately 2 years
Primary	Changes from baseline in safety laboratory parameters	Number of safety laboratory parameters reported as adverse events	From enrollment until end of treatment, up to approximately 2 years
Secondary	Assess the pharmacokinetics of BION-1301	Serum-time profiles and population PK parameters	From enrollment until end of treatment, up to approximately 2 years
Secondary	Characterize the pharmacodynamic effect of BION-1301	Changes from baseline in immunoglobulin levels (IgA, IgG, IgM levels)	From enrollment until end of treatment, up to approximately 2 years
Secondary	Assess the immunogenicity of BION-1301	Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs)	From enrollment until end of treatment, up to approximately 2 years