RecruitingPhase 2NCT07515014

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

Sponsor

Eisai Co., Ltd.

Enrollment

256 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called E6742 and Placebo for people with systemic lupus erythematosus. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGE6742

E6742 oral tablets.

OTHERPlacebo

Placebo oral tablets.

Locations(22)

Peking Union Medical College Hospital - East Campus

Beijing, Beijing Municipality, China

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School-Main

Nanjing, Jiangsu, China

Daido Clinic

Nagoya, Aichi-ken, Japan

Japan Community Health Care Organization (JCHO) Chukyo Hospital

Nagoya, Aichi-ken, Japan

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

University of Occupational and Environmental Health University Hospital

Kitakyushu, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaidô, Japan

Kobe University Hospital

Kobe, Hyôgo, Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, Japan

Shinkenko Clinic

Naha, Okinawa, Japan

Dokkyo Medical University Hospital

Mibu-Machi, Shimotsugagun, Tochigi, Japan

Juntendo University Hospital

Bunkyo, Tokyo, Japan

Tokyo Metropolitan Tama Medical Center

Fuchū, Tokyo, Japan

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Japan Institute for Health Security National Center for Global Health and Medicine

Shinjuku, Tokyo, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Hiroshima Prefectural Hospital

Hiroshima, Japan

Kumamoto Shinto General Hospital

Kumamoto, Japan

Niigata University Medical and Dental Hospital

Niigata, Japan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07515014

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