A Study of E6742 in Participants With Systemic Lupus Erythematosus

Sponsor
Eisai Co., Ltd.
Study ID
NCT07515014
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • E6742 — DRUG
    E6742 oral tablets.
  • Placebo — OTHER
    Placebo oral tablets.

Study Details

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).

Key Dates

First listed
Apr 7, 2026
Start date
Mar 31, 2026
Status verified
Jun 2026
Primary completion
Aug 5, 2028
Completion
Mar 1, 2029

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: E6742 Dose A
  • Experimental: E6742 Dose B
  • Experimental: E6742 Dose C

Primary Outcome Measure

Percentage of Participants who Achieve a BICLA Response with Low Dose of OCS (Prednisone or Equivalent) at Week 24 [ Time Frame: At Week 24 ]

Central Contacts

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