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Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04643470
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Zanubrutinib Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Zanubrutinib Low Dose
Participants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks
 Drug: Zanubrutinib
Administered as specified in the treatment arm
Other Names:
  • BGB-3111
  • Brukinsa
Experimental: Zanubrutinib High Dose
Participants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks
 Drug: Zanubrutinib
Administered as specified in the treatment arm
Other Names:
  • BGB-3111
  • Brukinsa
Experimental: Zanubrutinib Medium Dose
Participants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks
 Drug: Zanubrutinib
Administered as specified in the treatment arm
Other Names:
  • BGB-3111
  • Brukinsa
Experimental: Placebo
Participants will receive placebo to match zanubrutinib for 72 weeks
 Drug: Placebo
Placebo to match zanubrutinib


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with complete renal response [ Time Frame: Week 49 Day 1 ]

Secondary Outcome Measures :
  1. Proportion of participants achieving complete renal response [ Time Frame: Week 25 Day 1 ]
  2. Proportion of participants achieving partial renal response [ Time Frame: Week 25 Day 1 and Week 49 Day 1 ]
  3. Proportion of participants achieving overall renal response [ Time Frame: Week 25 Day 1 and Week 49 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 partial renal response [ Time Frame: Up to Week 73 Day 1 ]
    The time from the date of randomization to the date of the first partial renal response

  6. Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score [ Time Frame: Week 25 Day 1 and Week 49 Day 1 ]
    SLEDAI-2K score is an 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643470


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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China, Guangzhou
Guangdong General Hospital Recruiting
Guangdong, Guangzhou, China, 510000
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Zhen Yao, MD BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04643470    
Other Study ID Numbers: BGB-3111-217
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action