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Clinical Trials List

Protocol NumberCHK02-02 (Novartis CFUB523A12301)
NCT Number(ClinicalTrials.gov Identfier)NCT05852938
Active

2023-12-01 - 2029-06-30

Phase III

Recruiting8

ICD-10N05.0

Unspecified nephritic syndrome with minor glomerular abnormality

ICD-10N05.1

Unspecified nephritic syndrome with focal and segmental glomerular lesions

ICD-10N05.6

Unspecified nephritic syndrome with dense deposit disease

ICD-10N05.7

Unspecified nephritic syndrome with diffuse crescentic glomerulonephritis

ICD-10N05.8

Unspecified nephritic syndrome with other morphologic changes

ICD-10N06.0

Isolated proteinuria with minor glomerular abnormality

ICD-10N06.1

Isolated proteinuria with focal and segmental glomerular lesions

ICD-10N06.6

Isolated proteinuria with dense deposit disease

ICD-10N06.7

Isolated proteinuria with diffuse crescentic glomerulonephritis

ICD-10N06.8

Isolated proteinuria with other morphologic lesion

ICD-10N07.0

Hereditary nephropathy, not elsewhere classified with minor glomerular abnormality

ICD-10N07.1

Hereditary nephropathy, not elsewhere classified with focal and segmental glomerular lesions

ICD-10N07.6

Hereditary nephropathy, not elsewhere classified with dense deposit disease

ICD-10N07.7

Hereditary nephropathy, not elsewhere classified with diffuse crescentic glomerulonephritis

ICD-10N07.8

Hereditary nephropathy, not elsewhere classified with other morphologic lesions

ICD-10N14.0

Analgesic nephropathy

ICD-10N14.1

Nephropathy induced by other drugs, medicaments and biological substances

ICD-10N14.2

Nephropathy induced by unspecified drug, medicament or biological substance

ICD-10N14.3

Nephropathy induced by heavy metals

ICD-10N14.4

Toxic nephropathy, not elsewhere classified

ICD-10N15.0

Balkan nephropathy

ICD-10N15.8

Other specified renal tubulo-interstitial diseases

ICD-9583.89

Nephritis and nephropathy, not specified as acute or chronic, with other specified pathological lesion in kidney

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chung-Yi Cheng Division of Nephrology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳家麟 Division of Nephrology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 楊忠煒 Division of Nephrology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator VIN-CENT Wu Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Heng-Chih Pan 無
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Hsing Wu Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 徐邦治 Division of Nephrology
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Junne-Ming Sung
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

IgA Nephropathy 、Immunoglobulin A Nephropathy

Objectives

CHK02-02 (Novartis CFUB523A12301) is a phase 3, randomized, double-blind, placebo-controlled trial in adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of progressive renal loss. Randomization was stratified by region (Asia vs. all other regions), baseline proteinuria (≥ 2 g/day vs. < 2 g/day), and eGFR (≤ 45 mL/min/1.73 m2 vs. > 45 mL/min/1.73 m2). At a 1:1 ratio, approximately 330 participants in the primary cohort with an eGFR ≥ 30 mL/min/1.73 m² at screening will be randomly assigned to receive BION-1301, Novartis FUB523, or INN zigakibart (hereinafter referred to as "BION-1301") 600 mg every 2 weeks (Q2W) or a matched placebo for 104 weeks. Approximately 20 participants with an eGFR ≥ 20 and < 30 mL/min/1.73 m² may be included in the exploratory cohort, which will not be included in either the primary or secondary analyses. Enrollment in the exploratory cohort will only begin after a sufficient number of participants have been enrolled in the primary cohort; adequacy of the enrollment number is determined by the trial commissioner. The primary objective was to assess the effect of BION-1301 compared to placebo on proteinuria in adult patients with immunoglobulin A (IgA) nephropathy. The key secondary objective was to assess the effect of BION-1301 compared to placebo on estimated glomerular filtration rate (eGFR), with the endpoint being the annualized rate of change in eGFR. The secondary objectives were to assess the effect of BION-1301 compared to placebo on eGFR, with the endpoint being the change in eGFR from baseline, and to assess the effect of BION-1301 compared to placebo on specific clinical composite indicators during the trial period.

Test Drug

皮下注射劑

Active Ingredient

BION-1301

Dosage Form

220

Dosage

150 mg/mL , 2mL

Endpoints

Evaluating the effect of BION-1301 compared to placebo on proteinuria in adult patients with immunoglobulin A (IgA) nephropathy.

Inclution Criteria

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 Sponsor.
eGFR ≥ 30 mL/min/1.73m^2 at Screening based on the 2021 CKD-EPI equation.
Total urine protein ≥ 1.0 g/day or 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 angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.
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

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 therapy 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.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    350 participants

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