A Study of E6742 in Participants With Systemic Lupus Erythematosus

Sex: All

Ages: 18 Years – 75 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 256

Sponsor: Eisai Co., Ltd.

Location: The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui

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).

Eligibility Criteria

Inclusion Criteria: 1. Male or female adult, age \>=18 years (the minimum age may be different from 18 years in certain countries based on regional requirements) and \=1 organ system or BILAG-2004 category B in \>=2 organ systems at screening 4. SLEDAI-2K score \>=6 points at Screening AND Clinical SLEDAI-2K score \>=4 points at Baseline 5. Receiving at least one of the following treatments for SLE (if more than 1 treatment is used, all medications must be within the dosage defined in the protocol): 1. OCS (\

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Source: ClinicalTrials.gov (NCT07515014). StuddyBuddy aggregates publicly available trial information.