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A Study of BION-1301 in Adults With IgA Nephropathy

PHASE3RECRUITING

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

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Study details:

Approximately 272 participants with eGFR ≥ 30 mL/min/1. 73m\^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to \< 30 mL/min/1.

73 m\^2. The exploratory cohort will be randomized using the same schema as the primary cohort. The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy.

Participants will have assessments of safety and efficacy for 2. 5 years (up to 134 weeks). To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Male and female participants 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 diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Medical Monitor.

eGFR ≥ 30 mL/min/1.73m^2 at Screening based on the 2021 CKD-EPI equation.

Total urine protein ≥ 1.0 g/day and UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour 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 unless 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. Participants are expected to stay on the ACEi/ARB, SGLT2i and/or the ERAs/MRAs for the duration of the study.

Body mass index (BMI) between 18 and 40 kg/m^2.

Screening weight of 45 to 150 kg.

Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group [CTFG] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated > 1 month prior to first 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.

Current or history of nephrotic syndrome.

Average blood pressure > 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated once within the Screening period if clinically appropriate as per the Investigator.

Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines.

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.

Participants with Type 2 diabetes are excluded if any of the following are present: * Screening HbA1c (glycated hemoglobin) of > 8%. * Evidence of diabetic changes on kidney biopsy, performed for any reason. * History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy) and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular disease, cerebrovascular disease). * Unstable anti-diabetic regimen.

Prior exposure to any antibody directed against APRIL.

History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis, including a history of allergy or hypersensitivity to any component of BION-1301, or 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.

Any confirmed or suspected immunosuppressive or immune-deficient state, including but not limited to common variable immunodeficiency (CVID), HIV infection or asplenia, history of bone marrow or organ transplantation with exception of corneal transplants.

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

Positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody be allowed), or antibodies to HIV-1 and/or HIV-2 at Screening.

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.

History of malignancy unless cancer free for at least 5 years or non-melanoma skin cancer that was completely resected. A participant with curatively treated cervical carcinoma in situ is eligible for the study. Participants with low-risk prostate cancer (i.e., Gleason score < 7 and prostate specific antigen < 10 ng/mL) are allowed.

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

History or evidence of any other clinically significant disorder, condition, disease, or laboratory finding that, in the Investigator's assessment, would place the participant at unacceptable risk, limit compliance with study requirements, or confound interpretation of study results.

IgG levels < 6 g/L at Screening.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-07-27

Primary completion: 2026-02-19

Study completion finish: 2028-06-07

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05852938

Intervention or treatment

DRUG: BION-1301

DRUG: Placebo

Conditions

• IgA Nephropathy
• Immunoglobulin A Nephropathy

Condition: IgA Nephropathy, Immunoglobulin A Nephropathy
DRUG: BION-1301 and other drugs
Gosford, New South Wales, Australia and more
Sponsor: Chinook Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Novartis Investigative Site

Research sites nearby

Select from list below to view details:

Novartis Investigative Site
Gosford, New South Wales, Australia
Novartis Investigative Site
Kogarah, New South Wales, Australia
Novartis Investigative Site
Liverpool, New South Wales, Australia
Novartis Investigative Site
Penrith, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BION-1301 600mg subcutaneous administration every 2 weeks for 104 weeks	DRUG: BION-1301 BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.
PLACEBO_COMPARATOR: Placebo subcutaneous administration every 2 weeks for 104 weeks	DRUG: Placebo Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change in proteinuria (natural log UPCR)	The change in urine protein: creatinine ratio (UPCR) from baseline to Week 40.	40 weeks or approximately 9 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change in eGFR	The change in eGFR from baseline to Week 104.	104 weeks or approximately 2 years
Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)	Percent of participants meeting the composite endpoint of experiencing at least 1 of the following during the study: * At least 30% reduction in eGFR sustained for at least 30 days * eGFR \< 15 mL/min/1.73m\^2, sustained for at least 30 days * Chronic dialysis, ≥ 30 days * Kidney transplantation * All-cause mortality	Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)	Percent of participants meeting the composite endpoint of experiencing at least 1 of the following during the study: * At least 40% reduction in eGFR sustained for at least 30 days * eGFR \< 15 mL/min/1.73m\^2, sustained for at least 30 days * Chronic dialysis, ≥ 30 days * Kidney transplantation * All-cause mortality	Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
Percent Change in Proteinuria and Total Urine Protein	Percent of participants achieving reduction of proteinuria to \< 1.0 g/day at Week 40 and a ≥ 25% decrease in total urine protein from Baseline	40 weeks or approximately 9 months

Frequently Asked Questions

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References

Clinical Trials Gov: A Study of BION-1301 in Adults With IgA Nephropathy