BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02062684

Enrollment

Registered

2014-02-14

Start date

2013-06-30

Completion date

2017-06-30

Last updated

2017-09-18

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

Conditions

IgA Nephropathy

Keywords

IgAN, IgA Nephropathy, A-623, Blisibimod, Kidney Disease, Persistent proteinuria

Brief summary

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.

Interventions

DRUGBlisibimod

DRUGPlacebo

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 65 Years

Healthy volunteers

Inclusion criteria

* 18 - 65 years of age, inclusive * Biopsy-proven IgA nephropathy * Receiving stable, clinically-optimized ACEI and/or ARB * Proteinuria ≥ 1g/24hr but ≤ 6g/24hr at 2 consecutive time points

Exclusion criteria

* Clinical or histologic evidence of non-IgA-related glomerulonephritis * IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring * Meets eGFR criteria * History of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months * 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
Proportion of subjects achieving reduction in proteinuria from baseline	24 weeks

Secondary

Measure	Time frame
Change from baseline in serum immunoglobulins IgA, IgG and IgM	24 weeks
Percent reduction from baseline in plasma cells and B-cell subsets	24 weeks
Numbers of subjects requiring the addition of corticosteroid or other therapy	24 weeks
Proportion of subjects progressing to End Stage Renal Disease	Approximately 104 weeks
Proportion of subjects achieving reduction in proteinuria from baseline	Approximately 104 weeks
Percent change from baseline in complement C3 and C4	24 weeks

Countries

Czechia, Germany, Hong Kong, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom

Outcome results

None listed

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