BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02052219

Enrollment

Registered

2014-02-03

Start date

2014-10-31

Completion date

2021-10-31

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

Keywords

Blisibimod, IgA nephropathy, BAFF, BLyS

Brief summary

The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.

Interventions

DRUGBlisibimod

Blisibimod administered subcutaneously

DRUGPlacebo

Placebo administered subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age or older. * Biopsy-proven IgA nephropathy * Proteinuria ≥ 2g/24hr or equivalent * Receiving physician-directed optimized standard of care that includes ACEI and/or ARB. * Estimated glomerular filtration rate (eGFR) \>40mL/min/1.73m2

Exclusion criteria

* Clinical or histologic evidence of non-IgA-related glomerulonephritis * IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring * Meets eGFR criteria * Malignancy within past 5 years * Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C * Liver disease * Neutropenia * Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections * History of active tuberculosis or a history of tuberculosis infection * Pregnant or nursing

Design outcomes

Primary

Measure	Time frame
The proportion of subjects to achieve the proteinuria threshold	Week 24
The proportion of subjects who progress to end-stage renal disease	approximately 5 years

Secondary

Measure	Time frame
Change from baseline in serum creatinine	Week 24
Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets	Week 24
The proportion of subjects requiring the addition of corticosteroid or other therapy	Week 24
Change from baseline in eGFR	Week 24
Number of Participants with Adverse Events	Week 24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026