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A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus

NCT07751848 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2026-08-07

No results posted yet for this study

Summary

This study aims to describe clinical outcomes, with focus on remission, achieved with use of anifrolumab participants with SLE on standard-of-care (as recommended by 2025 China SLE guidelines). Further, it aims to describe outcomes alongside a systematic approach to glucocorticoid (GC) tapering, in terms of effectively minimising GC use, as well as discontinuing GC use, thereby reducing GC exposure.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Anifrolumab

The study intervention, anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes from Week 0 to Week 48 for a total of 13 doses. Each dose must be at least 14 days apart.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-04
Primary Completion
2028-08-25
Completion
2028-08-25

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751848 on ClinicalTrials.gov