Trial intelligence / Profile preview

Zanubrutinib in Active Proliferative Lupus Nephritis

NCT04643470Phase 2

Key facts

Status: Completed
Start: Dec 2020
Primary completion: Feb 2024
Countries: 1
Sponsor: BeiGene
Modality: Fragment-Derived Small Molecules, Reversible Covalent Inhibitors, Bivalent/Multivalent Binders

Drugs: zanubrutinib
Conditions: lupus nephritis (LN)

Overview

Phase 2, randomised, double-blind trial of zanubrutinib in lupus nephritis (LN) (4 arms), sponsored by BeiGene. Primary endpoint: Proportion of participants with complete renal response at Week 49. Started Dec 2020; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Zanubrutinib Low Dose
Zanubrutinib 40 mg BID + Standard of Care
Zanubrutinib High Dose
Zanubrutinib 160 mg BID + Standard of Care
Zanubrutinib Medium Dose
Zanubrutinib 160 mg QD + Standard of Care
Placebo
Placebo + Standard of Care

Who it enrols

Patients with active proliferative lupus nephritis (Class III/IV) and significant proteinuria.

Endpoints

Primary

Proportion of participants with complete renal responseWeek 49

Secondary

Proportion of participants achieving complete renal responseWeek 73
Proportion of participants achieving partial renal responseWeek 73
Proportion of participants achieving overall renal responseWeek 73
Time to first complete renal responseWeek 73
Time to first overall renal responseWeek 73
Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scoreWeek 49
Area under plasma concentration time curve (AUC) of zanubrutinibWeek 5

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