Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-18

Study Completion Date

2022-09-23

Brief Summary

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The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.

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Detailed Description

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Conditions

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Complement 3 Glomerulopathy Immunoglobulin A Nephropathy Membranous Nephropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Three parallel treatment cohorts based on diagnosis of C3G, IgAN, or PMN. All eligible participants will receive open-label BCX9930.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Administered orally at a dose of 200 mg twice daily for the first 2 weeks, then 400 mg twice daily

Interventions

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BCX9930

Administered orally at a dose of 200 mg twice daily for the first 2 weeks, then 400 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight ≥ 40 kilograms (kg)
* Primary diagnosis of C3G, IgAN, or PMN confirmed by central pathology review
* An estimated glomerular filtration rate (eGFR) ≥ 50 milliter per minute per 1.73 meter square (mL/min/1.73 m\^2) (or ≥ 30 mL/min/1.73 m\^2 after Data Monitoring Committee \[DMC\] recommendation)
* Receiving treatment with a stable, maximum recommended or maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 60 days prior to the Day 1 Visit
* Documentation of current vaccinations against Neisseria meningitidis and Streptococcus pneumoniae or willingness to start vaccination series

Exclusion Criteria

* Known congenital deficiency of C1s, C1r, C1q, C2, or C4
* History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation
* Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition
* History of malignancy within 5 years prior to the screening visit
* Active serious bacterial, viral, or fungal infection or any other serious infection within 14 days of screening
* Treatment with any systemic immunosuppressive or immunomodulatory therapy within 90 days OR anti-CD20 antibody therapies (eg, rituximab) within 180 days prior to the screening visit
* Treatment with renin inhibitors (eg, aliskiren) or sodium-glucose-cotransporter 2 (SGLT2) inhibitors within 60 days prior to Day 1

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No