Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

BeiGene

Status and phase: Completed; Phase 2

Conditions: Lupus Nephritis

Treatments: Drug: Placebo; Drug: Zanubrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04643470

BGB-3111-217

CTR20202662 (Other Identifier)

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis

Enrollment: 177 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria.
2. ISN/RPS 2003 Class III/IV lupus nephritis [Type III(A), III (A+C), IV (A), and IV (A+C)], with or without Class V, as confirmed by a renal biopsy.
3. Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
4. Has 24-hour urine protein excretion > 1.0 g at screening.

Key Exclusion Criteria:

Exclusion criteria related to systemic lupus erythematous and other diseases:

1. Glomerulonephritis caused by reasons other than systemic lupus erythematous.
2. Sclerosis in >50% of glomeruli on renal biopsy.
3. Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
4. Severe extrarenal SLE, including but not limited to severe pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric SLE, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 4 patient groups

Zanubrutinib Low Dose

Experimental group

Description:

Participants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks

Treatment:

Drug: Zanubrutinib

Zanubrutinib High Dose

Experimental group

Description:

Participants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks

Treatment:

Drug: Zanubrutinib

Zanubrutinib Medium Dose

Experimental group

Description:

Participants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks

Treatment:

Drug: Zanubrutinib

Placebo

Experimental group

Description:

Participants will receive placebo to match zanubrutinib for 72 weeks

Treatment:

Drug: Placebo