Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Zanubrutinib in Patients With Active Proliferative Lupus Nephritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04643470
• Other study ID #: BGB-3111-217
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 22, 2020
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 177
• Est. completion date: September 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Zanubrutinib
Administered as specified in the treatment arm
• Placebo
Placebo to match zanubrutinib

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangdong	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with complete renal response		Week 49 Day 1
Secondary	Proportion of participants achieving complete renal response		Up to Week 73 Day 1
Secondary	Proportion of participants achieving partial renal response		Up to Week 73 Day 1
Secondary	Proportion of participants achieving overall renal response		Up to Week 73 Day 1
Secondary	Time to first complete renal response	The time from the date of randomization to the date of the first complete renal response	Up to Week 73 Day 1
Secondary	Time to first overall renal response	The time from the date of randomization to the date of the first overall renal response	Up to Week 73 Day 1
Secondary	Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score	SLEDAI-2K score is a systemic lupus erythematosus (SLE) activity index based on the presence of 24 features in 9 organ systems which ranges from 0 - 105, with higher scores indicating more severe features in participants in the past 30 days	Baseline to Week 49 Day 1
Secondary	Area under plasma concentration time curve (AUC) of zanubrutinib		Week 1 Day 1 and Week 5 Day 1