Actively Recruiting
A Study of E6742 in Participants With Systemic Lupus Erythematosus
Led by Eisai Co., Ltd. · Updated on 2026-04-28
256
Participants Needed
17
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of E6742 in Participants With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 18 to 75 years
- Diagnosed with systemic lupus erythematosus at least 6 months prior and meeting 2019 EULAR/ACR criteria
- Have at least one organ system with BILAG-2004 category A or two or more organ systems with category B at screening
- SLEDAI-2K score of 6 or higher at screening and clinical SLEDAI-2K score of 4 or higher at baseline
- Receiving stable doses of one or more of the following: oral corticosteroids (up to 30 mg/day prednisone or equivalent), hydroxychloroquine (up to 400 mg/day), quinacrine (up to 200 mg/day), or specified immunosuppressants for specified durations before study drug
- Willing and able to provide written informed consent and follow the study protocol
You will not qualify if you...
- Pregnant or breastfeeding females at screening or baseline
- Females of childbearing potential not using highly effective contraception or unwilling to use it during and after the study
- Males without successful vasectomy if their female partners are of childbearing potential and unwilling to use contraception
- Drug-induced lupus erythematosus
- Active or unstable neuropsychiatric lupus
- Other systemic autoimmune diseases affecting SLE assessment, except certain secondary conditions
- Clinically significant abnormal findings in chest X-ray, eye exam, vital signs, ECG, or labs affecting safety or study
- Liver enzymes over 3 times upper limit, low neutrophil count, low platelets, or low hemoglobin at screening
- Renal impairment with urine protein/creatinine ratio over 2.0 or eGFR under 40 mL/min/1.73 m2
- Recent vaccination within 2 or 4 weeks depending on vaccine type
- Current or past gene therapy for SLE
- Participation in another clinical study or use of investigational drugs within 28 days before consent
- Recent serious infections or active tuberculosis
- Positive or indeterminate tuberculosis test
- Prolonged QTc interval or risk factors for torsade de pointes
- Hypersensitivity to study drug or its components
- Any medical condition compromising safe study participation
- Planned surgery requiring general, spinal, or epidural anesthesia during the study
- Positive HIV, hepatitis B, or hepatitis C tests
- Recent psychotic disorders or unstable affective disorders
- History of drug or alcohol abuse within 2 years
- History or current malignancy except certain cured skin or cervical cancers
- Investigator assessment deeming study participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Peking Union Medical College Hospital - East Campus
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School-Main
Nanjing, Jiangsu, China
Not Yet Recruiting
3
Daido Clinic
Nagoya, Aichi-ken, Japan
Not Yet Recruiting
4
Japan Community Health Care Organization (JCHO) Chukyo Hospital
Nagoya, Aichi-ken, Japan
Not Yet Recruiting
5
University of Occupational and Environmental Health University Hospital
Kitakyushu, Fukuoka, Japan
Actively Recruiting
6
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
7
Kobe University Hospital
Kobe, Hyōgo, Japan
Not Yet Recruiting
8
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Actively Recruiting
9
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi, Japan
Actively Recruiting
10
Shinkenko Clinic
Naha, Okinawa, Japan
Actively Recruiting
11
Juntendo University Hospital
Bunkyo, Tokyo, Japan
Not Yet Recruiting
12
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
Not Yet Recruiting
13
Japan Institute for Health Security National Center for Global Health and Medicine
Shinjuku, Tokyo, Japan
Not Yet Recruiting
14
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
Not Yet Recruiting
15
Hiroshima Prefectural Hospital
Hiroshima, Japan
Not Yet Recruiting
16
Kumamoto Shinto General Hospital
Kumamoto, Japan
Actively Recruiting
17
Niigata University Medical and Dental Hospital
Niigata, Japan
Not Yet Recruiting
Research Team
E
Eisai Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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