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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants

A Randomized, Double-Blind, Placebo-Controlled, Multi-center, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Patients

NCT05278663•Eisai Co., Ltd.

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to evaluate the safety and tolerability of multiple oral doses of E6742 in participants with systemic lupus erythematosus (SLE).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or Female, age greater than or equal to (\>=) 18 years and less than or equal to (\<=) 75 years at the time of written informed consent
•2. Body mass index (BMI) \>=15 kilogram per square meter (kg/m\^2) and less than (\<) 30 kg/m\^2 at screening
•3. Diagnosed with SLE according to 2019 The European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) classification criteria, Systemic Lupus International Collaborating Clinics Disease Index (SLICC) classification criteria (2012 version), or 1997 revised ACR classification criteria at least 6 months before the informed consent
•4. Meets at least one of the following criteria at screening:
•* Antinuclear antibody positive (\>=1:80)
•* Anti-double stranded deoxyribonucleic acid (DNA) antibody positive
•* Anti-smith antibody positive

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:
•• 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 or intrauterine hormone-releasing system (IUS)
•* a contraceptive implant
•* an oral contraceptive (Participant must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the study and for 28 days after study drug discontinuation)
•* have a vasectomized partner with confirmed azoospermia
•* Do not agree to use a highly effective method of contraception (as described above) 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 NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Approved or certificated for drugs or medical devices in Japan
+21 more criteria

Locations (12)

Chukyo Hospital

Nagoya, Aichi-ken, Japan

Daido Clinic

Nagoya, Aichi-ken, Japan

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Osaka University Hospital

Suita, Osaka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

St. Luke's International Hospital

Chuo-ku, Tokyo, Japan

Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Tama Medical Center

Fuchū, Tokyo, Japan

Key Dates

Start Date

April 14, 2022

Primary Completion Date

September 4, 2023

Completion Date

September 4, 2023

Last Updated

September 29, 2023

Enrollment

ACTUAL participants

Conditions

Lupus Erythematosus, Systemic

Interventions

E6742

DRUG

Placebo

OTHER

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Lupus Erythematosus, SystemicLupus Nephritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases