Loading clinical trials...

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

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

NCT04643470•BeiGene

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

Exclusion Criteria

•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.

Locations (44)

Anhui Provincial Hospital

Hefei, Anhui, China

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Peking University International Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

Guangzhou, Guangdong, China

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat Sen University

Guangzhou, Guangdong, China

The Third Affiliated Hospital, Sun Yat Sen University

Guangzhou, Guangdong, China

Guangdong Province Traditional Chinese Medical Hospitsal

Guangzhou, Guangdong, China

Key Dates

Start Date

December 22, 2020

Primary Completion Date

February 26, 2024

Completion Date

August 26, 2024

Last Updated

November 29, 2024

Enrollment

177

ACTUAL participants

Conditions

Lupus Nephritis

Interventions

Zanubrutinib

DRUG

Placebo

DRUG

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277

Lupus Nephritis

View study

RECRUITINGPHASE2

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Lupus Landmark Study: A Prospective Registry and Biorepository