A Study of E6742 in Participants With Systemic Lupus Erythematosus

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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 facts

Study ID: NCT07515014
Run by: Eisai Co., Ltd.
People needed: 256
Starts: 2026-03-31
Expected to finish: 2029-03-01
Last updated by the study team: 2026-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female adult, age >=18 years (the minimum age may be different from 18 years in certain countries based on regional requirements) and <=75 years at the time of informed consent
Diagnosed with SLE at least 6 months before the informed consent AND fulfill the 2019 EULAR/ACR classification criteria at Screening based on medical history
At least BILAG-2004 category A in >=1 organ system or BILAG-2004 category B in >=2 organ systems at screening
SLEDAI-2K score >=6 points at Screening AND Clinical SLEDAI-2K score >=4 points at Baseline
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):
OCS (<=30 mg/day, prednisone or equivalent): The dosing regimen should be stable for at least 4 weeks before the first dose of study drug.
Oral hydroxychloroquine (<=400 mg/day), quinacrine (<=200 mg/day): These medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the first dose.
Immunosuppressants: The following medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the first dose
Mycophenolate mofetil (<=3 g/day)
Mycophenolate sodium (<=2160 mg/day)
Azathioprine (<=200 mg/day)
6-mercaptopurine (<=100 mg/day)
Methotrexate (oral/subcutaneous/intramuscular) (<=25 mg/week)
Willing and able to provide written informed consent and comply with all aspects of the protocol

You may not qualify if…

Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG] test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Females of childbearing potential who:
Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
Total abstinence (if it is their preferred and usual lifestyle)
An intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
A contraceptive implant
Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral, injectable). Participants using hormonal contraceptives must be on a stable dose of the same contraceptive product for at least 28 days before dosing, throughout the study, and for at least 28 days following study drug discontinuation.
Have a vasectomized partner with confirmed azoospermia
Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation.
Participants on an oral contraceptive must use an additional barrier method throughout the study and for 28 days after study drug discontinuation.
Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (ie, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.
Drug-induced lupus erythematosus
Active or unstable neuropsychiatric lupus (including but not limited to any condition defined by BILAG category A in neuropsychiatric organ system)
Systemic autoimmune diseases other than SLE (eg, rheumatoid arthritis, Crohn's disease, systemic sclerosis [SSc], multiple sclerosis, polymyositis/ dermatomyositis [PM/DM]) that may affect the assessment of SLE pathology at Screening. The participants with the following diseases may be included in the study
Sjögren's syndrome secondary to SLE
Antiphospholipid antibody syndrome (APS) secondary to SLE
Mixed Connective Tissue Disease (MCTD) not meeting diagnostic criteria for PM and SSc
Any clinically significant symptom or organ impairment found by chest X-ray, ophthalmic examination, vital signs, or ECG finding at Screening or Baseline, laboratory test at Screening that in the opinion of the investigator could affect the participants safety or interfere with the study assessments.
Laboratory test results meeting any of the following criteria at Screening:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3× upper limit of normal (ULN)
Absolute neutrophil count (ANC) <1,000 /mcL
Platelet count <50,000 /mcL
Hemoglobin <8.0 g/dL
Renal impairment falling under any of the following criteria at Screening:
Urine protein/creatinine ratio >2.0 g/gCr

Where it is running

Tokyo Metropolitan Tama Medical Center — Fuchū, Tokyo, Japan (enrolling)
Peking Union Medical College Hospital - East Campus — Beijing, Beijing Municipality, China (enrolling)
Nanfang Hospital Southern Medical University - PPDS — Guangzhou, Guangdong, China (enrolling)
University of Occupational and Environmental Health University Hospital — Kitakyushu, Fukuoka, Japan (enrolling)
Hokkaido University Hospital — Sapporo, Hokkaidô, Japan (enrolling)
Kobe University Hospital — Kobe, Hyôgo, Japan (enrolling)
Hyogo Medical University Hospital — Nishinomiya, Hyōgo, Japan (enrolling)
Tohoku Medical and Pharmaceutical University Hospital — Sendai, Miyagi, Japan (enrolling)
Shinkenko Clinic — Naha, Okinawa, Japan (enrolling)
Juntendo University Hospital — Bunkyo, Tokyo, Japan (enrolling)
Toho University Omori Medical Center — Ōta-ku, Tokyo, Japan (enrolling)
Japan Institute for Health Security National Center for Global Health and Medicine — Shinjuku, Tokyo, Japan (enrolling)
National Hospital Organization Kyushu Medical Center — Fukuoka, Japan (enrolling)
Hiroshima Prefectural Hospital — Hiroshima, Japan (enrolling)
Kumamoto Shinto General Hospital — Kumamoto, Japan (enrolling)
Niigata University Medical and Dental Hospital — Niigata, Japan (enrolling)
Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (enrolling)
The First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China (enrolling)
The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (enrolling)
The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
The First Affiliated Hospital of Nanchang University - Donghu Campus — Nanchang, Jiangxi, China (enrolling)
Pingxiang People's Hospital — Pingxiang, Jiangxi, China (enrolling)
The Second Affiliated Hospital, Zhejiang University School of Medicine - Jiefanglu Campus — Hangzhou, Zhejiang, China (enrolling)
Daido Clinic — Nagoya, Aichi-ken, Japan (enrolling)

Full record on ClinicalTrials.gov

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