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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    24
  • sponsor
    Eisai Co., Ltd.
Updated on 23 July 2022
body mass index
antinuclear antibody

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).

Details
Condition Lupus Erythematosus, Systemic
Treatment Placebo, E6742
Clinical Study IdentifierNCT05278663
SponsorEisai Co., Ltd.
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Body mass index (BMI) >=15 kilogram per square meter (kg/m^2) and less than (<) 30 kg/m^2 at screening
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
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

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 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
Males who have not had a successful vasectomy (confirmed azoospermia) if their female
partners meet the exclusion criteria above (that is, 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
Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles of E6742 (example, hepatectomy, nephrectomy, digestive organ resection) at screening
Scheduled for surgery during the study
A prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) (Fridericia method) interval (QTcF greater than [>] 450 millisecond [ms]) as demonstrated by a repeated ECG at screening or baseline. A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QTcF interval except for hydroxychloroquine
Psychotic disorders or unstable recurrent affective disorders evident by use of antipsychotics within 2 years before screening
History of drug or alcohol dependency or abuse within 2 years before screening
History of drug allergy or allergy to any investigational product excipients at screening
Known to be human immunodeficiency virus (HIV) positive at screening
Positive on test at screening for hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus core antibody (HBc antibody), hepatitis B virus DNA (HBV DNA), hepatitis C virus antibody (HCV antibody), human T-lymphotrophic virus Type I antibody (HTLV-1 antibody), or syphilis
History of clinically significant infections such as latent infectious viruses
History of infections requiring hospitalization or intravenous antibiotics, or administration of antiviral drugs, within 4 weeks before the first dose of study drug
History of active tuberculosis
Any findings indicating a history of tuberculosis on chest X-ray at screening
Currently enrolled in another clinical study or used any investigational drug or device within 16 weeks (or 5 half-lives, whichever is longer) before informed consent
Received vaccination within 4 weeks before the study treatment (8 weeks before in case of live vaccine)
Any history of or concomitant medical condition that in the opinion of the investigators would compromise the participant's ability to safely complete the study
Any clinically significant symptom or organ impairment
Drug induced lupus erythematosus
Active or unstable neuropsychiatric lupus
Renal impairment at Screening
Systemic autoimmune diseases other than SLE (example, rheumatoid arthritis, Crohn's disease, scleroderma, multiple sclerosis.) that may affect the assessment of SLE pathology
History of or complications from 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)
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