A Study of E6742 in Participants With Systemic Lupus Erythematosus

NCT07515014 | Recruiting Phase 2 FDA Drug

• 1 other identifier: E6742-G000-201
• Study Type: interventional
• Target: 256
• Locations: 2 countries
• Sites: 17

Brief 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).

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieve a BICLA Response with Low Dose of OCS (Prednisone or Equivalent) at Week 24

  The BICLA is a composite index used to assess disease activity in SLE. A BICLA response is defined as reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; no BILAG-2004 worsening in other organ systems, as defined by greater than or equal to (\>=1) new BILAG-2004 A or \>= 2 new BILAG-2004 B; no worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) as defined as an increase from baseline of greater than (\>) 0 points in SLEDAI-2K; no worsening from baseline in participants lupus disease activity defined by an increase \>=0.30 points on a 3-point Physician Global Assessment Visual Analogue Scale (PGA VAS); and no treatment failure.

  At Week 24

Secondary Outcomes (30)

• Percentage of Participants who Achieve an SLE Responder Index- 4 (SRI-4) Response with Low Dose of OCS (Prednisone or Equivalent) at Week 24

  At Week 24

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent SAEs

  From baseline up to 52 weeks

• Number of Participants With Clinically Significant Changes in Laboratory Parameters

  From baseline up to 52 weeks

• Number of Participants With Clinically Significant Changes in Vital Signs

  From baseline up to 52 weeks

• Frequency and Percentage of Abnormal Findings in 12-lead Electrocardiogram (ECG) Parameters

  From baseline up to 52 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Other: Placebo

E6742 Dose A

EXPERIMENTAL

Drug: E6742

E6742 Dose B

EXPERIMENTAL

Drug: E6742

E6742 Dose C

EXPERIMENTAL

Drug: E6742

Interventions

E6742 DRUG

E6742 oral tablets.

E6742 Dose A; E6742 Dose B; E6742 Dose C

Placebo OTHER

Placebo oral tablets.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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.
• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (17)

Peking Union Medical College Hospital - East Campus

Beijing, Beijing Municipality, China

NOT YET RECRUITING

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

Nanjing, Jiangsu, China

NOT YET RECRUITING

Daido Clinic

Nagoya, Aichi-ken, Japan

NOT YET RECRUITING

Japan Community Health Care Organization (JCHO) Chukyo Hospital

Nagoya, Aichi-ken, Japan

NOT YET RECRUITING

University of Occupational and Environmental Health University Hospital

Kitakyushu, Fukuoka, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

RECRUITING

Kobe University Hospital

Kobe, Hyōgo, Japan

NOT YET RECRUITING

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

RECRUITING

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, Japan

RECRUITING

Shinkenko Clinic

Naha, Okinawa, Japan

RECRUITING

Juntendo University Hospital

Bunkyo, Tokyo, Japan

NOT YET RECRUITING

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

NOT YET RECRUITING

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

Shinjuku, Tokyo, Japan

NOT YET RECRUITING

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

NOT YET RECRUITING

Hiroshima Prefectural Hospital

Hiroshima, Japan

NOT YET RECRUITING

Kumamoto Shinto General Hospital

Kumamoto, Japan

RECRUITING

Niigata University Medical and Dental Hospital

Niigata, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Eisai Medical Information

CONTACT

+1-888-274-2378; esi_medinfo@eisai.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 7, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): August 5, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (2); JP (15)