Systemic Lupus Erythematosus
Conditions
Interventions
The placebo or E6742 (100 mg/200 mg) will be administered orally twice daily for 12 weeks.
Sponsors
Nakagawa Masaki
Japan Agency for Medical Research and Development (AMED)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or Female, age >=18 years and =15 kg/m2 and <30 kg/m2 at Screening 3.Diagnosed with SLE according to 2019 EULAR/ACR classification criteria, 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 -Anti-dsDNA antibody positive -Anti-Sm antibody positive
Exclusion criteria
Exclusion criteria: 1.Females who are breastfeeding or pregnant at Screening or Baseline. 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 -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. 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.Any history of surgery that may affect PK profiles of E6742 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening 5.Scheduled for surgery during the study 6.A prolonged QTcF (Fridericia method) interval (QTcF >450 ms) as demonstrated by a repeated ECG at Screening or Baseline. A history of 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. 7.Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics within 2 years before Screening 8.History of drug or alcohol dependency or abuse within 2 years before Screening 9.History of drug allergy or allergy to any investigational product excipients at Screening 10.Known to be human immunodeficiency virus (HIV) positive 11.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 12.History of clinically significant infections such as latent infectious viruses 13.History of infections requiring hospitalization or intravenous antibiotics, or administration of antiviral drugs, within 4 weeks before the first dose of study drug 14.History of active tuberculosis 15.Any findings indicating a history of tuberculosis on chest X-ray at Screening 16.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 17.Received vaccination within 4 weeks before the study treatment (8 weeks before in case of live vaccine) 18.Any history of or concomitant medical condition that in the opinion of the investigators would compromise the subject's ability to safely complete the study 19.Any clinically significant symptom or organ impairment found at Screening or Baseline. 20.Drug induced lupus erythematosus 21.Active or unstable neuropsychiatric lupus 22.Having renal impairment falling at Screening 23.Systemic autoimmune diseases other than SLE (eg, rheumatoid arthritis, Crohn's disease, scleroderma, multiple s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Contacts
Public ContactInquiry service
Eisai Co., Ltd.
Outcome results
None listed