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Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

Primary Purpose

Lupus Nephritis

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Zanubrutinib

Placebo

About this trial

This is an interventional treatment trial for Lupus Nephritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Zanubrutinib Low Dose

Zanubrutinib High Dose

Zanubrutinib Medium Dose

Placebo

Arm Description

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

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

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

Participants will receive placebo to match zanubrutinib for 72 weeks

Outcomes

Primary Outcome Measures

Proportion of participants with complete renal response

Secondary Outcome Measures

Proportion of participants achieving complete renal response

Proportion of participants achieving partial renal response

Proportion of participants achieving overall renal response

Time to first complete renal response

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

Time to first overall renal response

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

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

Area under plasma concentration time curve (AUC) of zanubrutinib

Full Information

NCT ID

NCT04643470

First Posted

November 18, 2020

Last Updated

March 20, 2023

Sponsor

BeiGene

1. Study Identification

Unique Protocol Identification Number

NCT04643470

Brief Title

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 22, 2020 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Nephritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

177 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zanubrutinib Low Dose

Arm Type

Experimental

Arm Description

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

Arm Title

Zanubrutinib High Dose

Arm Type

Experimental

Arm Description

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

Arm Title

Zanubrutinib Medium Dose

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Participants will receive placebo to match zanubrutinib for 72 weeks

Intervention Type

Drug

Intervention Name(s)

Zanubrutinib

Other Intervention Name(s)

BGB-3111, Brukinsa

Intervention Description

Administered as specified in the treatment arm

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match zanubrutinib

Primary Outcome Measure Information:

Title

Proportion of participants with complete renal response

Time Frame

Week 49 Day 1

Secondary Outcome Measure Information:

Title

Proportion of participants achieving complete renal response

Time Frame

Up to Week 73 Day 1

Title

Proportion of participants achieving partial renal response

Time Frame

Up to Week 73 Day 1

Title

Proportion of participants achieving overall renal response

Time Frame

Up to Week 73 Day 1

Title

Time to first complete renal response

Description

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

Time Frame

Up to Week 73 Day 1

Title

Time to first overall renal response

Description

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

Time Frame

Up to Week 73 Day 1

Title

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

Description

Time Frame

Baseline to Week 49 Day 1

Title

Area under plasma concentration time curve (AUC) of zanubrutinib

Time Frame

Week 1 Day 1 and Week 5 Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhen Yao, MD

Organizational Affiliation

BeiGene

Official's Role

Study Director

Facility Information:

Facility Name

Guangdong General Hospital

City

Guangdong

State/Province

Guangzhou

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

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