New lupus drug E6742 enters Mid-Stage trial

NCT ID NCT07515014

Disease control Sponsor: Eisai Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether the experimental drug E6742 can reduce lupus disease activity better than a placebo. About 256 adults with lupus will take either E6742 or a placebo pill for 24 weeks. The main goal is to see if more people on E6742 achieve a meaningful reduction in symptoms while using a low dose of steroids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: E6742
What this could lead to: If successful, this could point toward a new treatment option for lupus that helps control disease activity while allowing lower steroid doses.
What could go wrong: This is an early phase 2 trial with only 256 participants, so results may not apply to all lupus patients. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \<=75 years at the time of informed consent 2. 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 3. At least BILAG-2004 category A in \>=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 (\<=30 mg/day, prednisone or equivalent): The dosing regimen should be stable for at least 4 weeks before the first dose of study drug. 2. 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. 3. 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) 6. Willing and able to provide written informed consent and comply with all aspects of the protocol Exclusion Criteria 1. 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. 2. Females of childbearing potential who: 1. 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 2. Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation. 3. Participants on an oral contraceptive must use an additional barrier method throughout the study and for 28 days after study drug discontinuation. 3. 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. 4. Drug-induced lupus erythematosus 5. Active or unstable neuropsychiatric lupus (including but not limited to any condition defined by BILAG category A in neuropsychiatric organ system) 6. 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 7. 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. 8. 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 9. Renal impairment falling under any of the following criteria at Screening: * Urine protein/creatinine ratio \>2.0 g/gCr * Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\]) \<40 mL/min/1.73 m\^2 10. Received vaccination within 2 weeks before the first dose of study drug (4 weeks before in case of live/ live attenuated vaccines) 11. Currently or previously receiving gene therapy for SLE (eg, CAR-T cell therapy) 12. Currently enrolled in another clinical study or used any investigational drug or device (including E6742) within 28 days (or 5× the half-life, whichever is longer) before obtaining informed consent 13. Any history of the following clinically significant infections: * Infections requiring hospitalization or intravenous antibiotics, or administration of antiviral drugs, within 4 weeks before the first dose of study drug * Active tuberculosis 14. Any findings indicating a history of tuberculosis on chest X-ray at Screening 15. Positive or repeated hold (indeterminate or intermediate) in tuberculosis test (Interferon-γ release assays) at Screening 16. A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 millisecond (ms) according to central reading at Screening. If the QTcF machine read is greater than 440 ms on the first single 12-lead ECG, 2 additional 12-lead ECGs will be performed 1 minute apart and the mean of the 3 QTcF values will be used for evaluation. 17. A prolonged QTcF interval (mean QTcF \>450 ms) as demonstrated by triplicated ECGs at Baseline. Has any risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QTcF interval (excluding hydroxychloroquine). 18. Hypersensitivity to the study drug, drug product chemical derivate or any of the excipients at Screening 19. Any history of or concomitant medical condition that in the opinion of the investigators would compromise the participants ability to safely complete the study 20. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with study procedures and participant safety 21. Positive on test at Screening for human immunodeficiency virus (HIV) 22. Positive on test at Screening for hepatitis B virus (HBV) with a detectable (eg, hepatitis B virus surface \[HBs\] antigen reactive, HBs antibody, hepatitis B virus core \[HBc\] antibody, HBV deoxyribose nucleic acid (DNA)) or hepatitis C virus (HCV) with a detectable (eg, HCV ribonucleic acid (RNA) \[qualitative\], HCV antibody) viral load 23. Psychotic disorders or unstable recurrent affective disorders evident by use of antipsychotics within 2 years before Screening 24. History of drug or alcohol dependency or abuse within 2 years before Screening 25. History or concurrent of malignancy, lymphoma, leukemia, or lymphoproliferative disease (except for basal cell skin cancer, squamous cell skin cancer, and cervical cancer that have been cured by surgical operation) 26. Assessed to be inappropriate for clinical study by investigators

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

54 sites in 4 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Beijing Friendship Hospital, Capital Medical University - PPDS
RECRUITING

Beijing, Beijing Municipality, China
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
NOT_YET_RECRUITING

Kaohsiung City, Taiwan
Chang Gung Memorial Hospital, Linkou
RECRUITING

Taoyuan, Taiwan
Chonnam National University Hospital
NOT_YET_RECRUITING

Gwangju, South Korea
Chung Shan Medical University Hospital
NOT_YET_RECRUITING

Taichung, Taiwan
Daegu Catholic University Medical Center
NOT_YET_RECRUITING

Daegu, South Korea
Daido Clinic
RECRUITING

Nagoya, Aichi-ken, Japan
Dokkyo Medical University Hospital
RECRUITING

Mibu-Machi, Shimotsugagun, Tochigi, Japan
First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING

Kunming, Yunnan, China
First Hospital of Shanxi Medical University
NOT_YET_RECRUITING

Taiyuan, Shanxi, China
Fujita Health University Hospital
RECRUITING

Toyoake, Aichi-ken, Japan
Guangdong Provincial People's Hospital
RECRUITING

Guangzhou, Guangdong, China
Hiroshima Prefectural Hospital
RECRUITING

Hiroshima, Japan
Hokkaido University Hospital
RECRUITING

Sapporo, Hokkaidô, Japan
Hyogo Medical University Hospital
RECRUITING

Nishinomiya, Hyōgo, Japan
Japan Community Health Care Organization (JCHO) Chukyo Hospital
RECRUITING

Nagoya, Aichi-ken, Japan
Japan Institute for Health Security National Center for Global Health and Medicine
RECRUITING

Shinjuku, Tokyo, Japan
Jilin Province People's Hospital
RECRUITING

Changchun, Jilin, China
Jiujiang No.1 People's Hospital
RECRUITING

Jiujiang, Jiangxi, China
Juntendo University Hospital
RECRUITING

Bunkyo, Tokyo, Japan
Kaohsiung Veterans General Hospital
RECRUITING

Kaohsiung City, Taiwan
Kobe University Hospital
RECRUITING

Kobe, Hyôgo, Japan
Kumamoto Shinto General Hospital
RECRUITING

Kumamoto, Japan
Linfen Central Hospital
RECRUITING

Linfen, Shanxi, China
Nanfang Hospital Southern Medical University - PPDS
RECRUITING

Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School-Main
RECRUITING

Nanjing, Jiangsu, China
National Hospital Organization Kyushu Medical Center
RECRUITING

Fukuoka, Japan
Niigata University Medical and Dental Hospital
RECRUITING

Niigata, Japan
Okayama University Hospital
RECRUITING

Okayama, Japan
Peking Union Medical College Hospital - East Campus
RECRUITING

Beijing, Beijing Municipality, China
People's Hospital of Ningxia Hui Aotonomous Region
RECRUITING

Yinchuan, Ningxia, China
Pingxiang People's Hospital
RECRUITING

Pingxiang, Jiangxi, China
Shanxi Bethune Hospital
RECRUITING

Taiyuan, Shanxi, China
Shinkenko Clinic
RECRUITING

Naha, Okinawa, Japan
Taipei Veterans General Hospital
RECRUITING

Taipei, Taiwan
The Affiliated Hospital of Guizhou Medical University
RECRUITING

Guiyang, Guizhou, China
The First Affiliated Hospital of Bengbu Medical University
RECRUITING

Bengbu, Anhui, China
The First Affiliated Hospital of Guangxi Medical University
RECRUITING

Nanning, Guangxi, China
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
RECRUITING

Luoyang, Henan, China
The First Affiliated Hospital of Nanchang University - Donghu Campus
RECRUITING

Nanchang, Jiangxi, China
The First Affiliated Hospital of Shantou University Medical College
RECRUITING

Shantou, Guangdong, China
The First Affiliated Hospital of Soochow University - Pinghailu Campus
RECRUITING

Suzhou, Jiangsu, China
The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus
RECRUITING

Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Soochow University
RECRUITING

Suzhou, Jiangsu, China
The Second Affiliated Hospital, Zhejiang University School of Medicine - Jiefanglu Campus
RECRUITING

Hangzhou, Zhejiang, China
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING

Changsha, Hunan, China
The Third Affiliated Hospital, Sun Yat-Sen University
NOT_YET_RECRUITING

Guangzhou, Guangdong, China
Toho University Omori Medical Center
RECRUITING

Ōta-ku, Tokyo, Japan
Tohoku Medical and Pharmaceutical University Hospital
RECRUITING

Sendai, Miyagi, Japan
Tokyo Metropolitan Tama Medical Center
RECRUITING

Fuchū, Tokyo, Japan
University of Occupational and Environmental Health University Hospital
RECRUITING

Kitakyushu, Fukuoka, Japan
West China Hospital Sichuan University
RECRUITING

Chengdu, Sichuan, China
Xinxiang Central Hospital
RECRUITING

Xinxiang, Henan, China
Yichang Central People's Hospital - Xiling Campus
RECRUITING

Yichang, Hubei, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.