NCT04643470 is a Phase 2 clinical trial of Zanubrutinib in Lupus Nephritis, sponsored by BeiGene.

Who is sponsoring NCT04643470?

NCT04643470 is sponsored by BeiGene.

What drugs are being tested in NCT04643470?

Interventions in NCT04643470: Zanubrutinib, Placebo.

What condition does NCT04643470 study?

NCT04643470 studies Lupus Nephritis.

Is NCT04643470 still recruiting?

NCT04643470 is currently completed. Last updated 29 November 2024.

Last reviewed 2024-11-29 · How we verify

NCT04643470

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

Completed Phase 2 Last updated 29 November 2024

What this trial tests

Phase 2 trial testing Zanubrutinib in Lupus Nephritis in 177 participants. Completed in 26 August 2024.

Timeline

22 December 2020

Primary endpoint
26 February 2024

26 August 2024

Quick facts

Lead sponsor	BeiGene
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	177
Start date	22 December 2020
Primary completion	26 February 2024
Estimated completion	26 August 2024
Sites	44 locations across China

Drugs / interventions tested

Zanubrutinib (ZANUBRUTINIB) — full drug profile →
Placebo

Conditions studied

Lupus Nephritis — all drugs for Lupus Nephritis →

Sponsor

BeiGene — full company profile →

Who can join

Adults 18 to 70, any sex, with Lupus Nephritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Bruton's Tyrosine Kinase (BTK) Inhibitors and Autoimmune Diseases: Making Sense of BTK Inhibitor Specificity Profiles and Recent Clinical Trial Successes and Failures.
Ringheim GE, Wampole M, Oberoi K. · · 2021 · cited 100× · PMID 34803999 · DOI 10.3389/fimmu.2021.662223
BTK inhibitors in the treatment of hematological malignancies and inflammatory diseases: mechanisms and clinical studies.
Alu A, Lei H, Han X, Wei Y, et al · · 2022 · cited 88× · PMID 36183125 · DOI 10.1186/s13045-022-01353-w
Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
Bruton's Kinase Inhibitors for the Treatment of Immunological Diseases: Current Status and Perspectives.
Robak E, Robak T. · · 2022 · cited 45× · PMID 35628931 · DOI 10.3390/jcm11102807
Recent advances in immunotherapies for lupus nephritis.
Kaneko M, Jackson SW. · · 2023 · cited 17× · PMID 35778517 · DOI 10.1007/s00467-022-05670-7
Lupus Nephritis: Current Perspectives and Moving Forward.
Lichtnekert J, Anders HJ, Lech M. · · 2022 · cited 16× · PMID 36483271 · DOI 10.2147/jir.s363722
Novel Therapeutics for Management of Lupus Nephritis: What Is Next?
Thakare SB, So PN, Rodriguez S, Hassanein M, et al · · 2023 · cited 6× · PMID 37533564 · DOI 10.1016/j.xkme.2023.100688
Prioritizing drug targets in systemic lupus erythematosus from a genetic perspective: a druggable genome-wide Mendelian randomization study.
Gao Y, Zhou Y, Lin Z, Chen F, et al · · 2024 · cited 3× · PMID 38997544 · DOI 10.1007/s10067-024-07059-3

Verify or expand the search:

Other trials of Zanubrutinib

Trials testing the same drug.

NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR · Phase 2 · not yet recruiting
NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel · Phase 1 · recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting

Other recruiting trials for Lupus Nephritis

Currently open trials in the same condition.

NCT07523542 — SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus · Phase 1, PHASE2 · recruiting
NCT07109986 — UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis · Phase 1 · recruiting
NCT07053891 — LUPKYNIS Drug-use Results Survey · recruiting
NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
NCT06711887 — Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants · Phase 3 · recruiting

Other BeiGene trials

Trials by the same sponsor.

NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob · Phase 4 · recruiting
NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum · Phase 2 · active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB- · Phase 1 · active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04643470 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 29 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04643470.

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