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NOT YET RECRUITING
NCT07814664
PHASE2/PHASE3

Ivarmacitinib Versus Glucocorticoids in Mild-to-Moderate Systemic Lupus Erythematosus

Sponsor: Chinese SLE Treatment And Research Group

View on ClinicalTrials.gov

Summary

This randomized, double-blind, parallel-group, noninferiority clinical trial will evaluate the efficacy and safety of ivarmacitinib compared with oral prednisone in participants with mild-to-moderate active systemic lupus erythematosus (SLE) without active major organ involvement. Approximately 294 participants will be randomized in a 1:1 ratio to receive either ivarmacitinib 8 mg once daily or oral prednisone starting at 30 mg/day with a prespecified tapering schedule, together with the corresponding matching placebo, for 24 weeks. The study will assess whether ivarmacitinib is noninferior to oral prednisone in achieving the primary efficacy outcome. The primary outcome is the proportion of participants achieving remission of arthritis and/or rash, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), at Week 12. Safety and secondary efficacy outcomes will be evaluated throughout the 24-week treatment period.

Official title: Safety and Efficacy of Ivarmacitinib Versus Glucocorticoids in Patients With Mild-to-Moderate Systemic Lupus Erythematosus: A Randomized, Double-Blind, Noninferiority Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

294

Start Date

2026-10-15

Completion Date

2028-09-30

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

Ivarmacitinib Sulfate Tablets

Ivarmacitinib sulfate tablets, 8 mg orally once daily, plus matching prednisone acetate placebo tablets for 24 weeks. Stable background standard-of-care therapy is permitted.

DRUG

Prednisone Acetate Tablets

Prednisone acetate tablets administered orally once daily, starting at 30 mg/day and tapered according to the protocol-specified schedule. Participants will also receive matching placebo tablets for ivarmacitinib once daily. Stable background standard-of-care therapy is permitted.

Locations (1)

Peking Union Medical College Hospital

Beijing, China