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Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04643470
Collaborator
(none)
200
Enrollment
1
Location
4
Arms
31.3
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 22, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

    Primary Outcome Measures

    1. Proportion of participants with complete renal response [Week 49 Day 1]

    Secondary Outcome Measures

    1. Proportion of participants achieving complete renal response [Week 25 Day 1]

    2. Proportion of participants achieving partial renal response [Week 25 Day 1 and Week 49 Day 1]

    3. Proportion of participants achieving overall renal response [Week 25 Day 1 and Week 49 Day 1]

    4. Time to first complete renal response [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 [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 [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 [Week 1 Day 1 and Week 5 Day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Guangdong General Hospital Guangdong Guangzhou China 510000

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Zhen Yao, MD, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04643470
    Other Study ID Numbers:
    • BGB-3111-217
    First Posted:
    Nov 25, 2020
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Nephritis
    Lupus Nephritis
    Zanubrutinib

    Study Results

    No Results Posted as of Apr 21, 2022