NCT07515014

A Study of E6742 in Participants With Systemic Lupus Erythematosus

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Response Study to Evaluate the Efficacy and Safety of E6742 in Subjects With Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to demonstrate the efficacy based on dose response of E6742 compared with placebo as defined by the proportion of participants achieving a response using the British Isles Lupus Assessment Group (BILAG) based Composite Lupus Assessment (BICLA) with a low dose of oral corticosteroids (OCS) (prednisone or equivalent) at Week 24 in participants with systemic lupus erythematosus (SLE).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	E6742	E6742 oral tablets.
OTHER	Placebo	Placebo oral tablets.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-08-05
• Completion: 2029-03-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study