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Completed

NCT Number: NCT04643470

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria.
  • 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.
  • Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
  • Has 24-hour urine protein excretion > 1.0 g at screening.

Key Exclusion Criteria:

Exclusion criteria

related to systemic lupus erythematous and other diseases:

  • Glomerulonephritis caused by reasons other than systemic lupus erythematous.
  • Sclerosis in >50% of glomeruli on renal biopsy.
  • Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
  • 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.

Treatment and study plan

Zanubrutinib

Drug

Administered as specified in the treatment arm

Other names: BGB-3111, Brukinsa

Placebo

Drug

Placebo to match zanubrutinib

Primary outcomes

  1. Proportion of participants with complete renal response

    Time frame: Week 49 Day 1

Secondary outcomes

  1. Proportion of participants achieving complete renal response

    Time frame: Up to Week 73 Day 1

  2. Proportion of participants achieving partial renal response

    Time frame: Up to Week 73 Day 1

  3. Proportion of participants achieving overall renal response

    Time frame: Up to Week 73 Day 1

  4. Time to first complete renal response

    Time frame: Up to Week 73 Day 1

    The time from the date of randomization to the date of the first complete renal response

  5. Time to first overall renal response

    Time frame: Up to Week 73 Day 1

    The time from the date of randomization to the date of the first overall renal response

  6. Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

    Time frame: Baseline to Week 49 Day 1

    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

  7. Area under plasma concentration time curve (AUC) of zanubrutinib

    Time frame: Week 1 Day 1 and Week 5 Day 1

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2020
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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