A Study to Assess the Safety and Tolerability of E6742 in Systemic Lupus Erythematosus Patients

JRCT ID: jRCT2041210137

Registered date:28/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 14/04/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): The placebo or E6742 (100 mg/200 mg) will be administered orally twice daily for 12 weeks.

Outcome(s)

• Primary Outcome: safety and tolerability
• Secondary Outcome: Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1.Male or Female, age >=18 years and <=75 years at the time of written informed consent
2.Body mass index (BMI) >=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

Exclude 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 sclerosis.) that may affect the assessment of SLE pathology
24.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)

Related Information

• Primary Sponsor: Nakagawa Masaki
• Secondary Sponsor: Japan Agency for Medical Research and Development (AMED)
• Secondary ID(s): NCT05278663