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

NCT05278663 | Completed Phase 1

• 2 other identifiers: E6742-J081-101jRCT2041210137
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 12

Brief 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).

Conditions

Lupus Erythematosus, Systemic

Keywords

E6742

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs; laboratory evaluation for hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of physical examinations and chest X-ray test.

  Screening up to 28 days after the last dose of study drug at Day 85 (up to approximately 1 year 5 months)

Secondary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Days 1 and 15

  Days 1 and 15: 0-6 hours post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E6742 and its Metabolite (ER-001132963) on Days 1 and 15

  Days 1 and 15: 0-6 hours post-dose

• AUC(0-6Hours): Area Under the Plasma Concentration Versus Time Curve from Time 0 to 6 Hours for E6742 and its Metabolite (ER-001132963) on Days 1 and 15

  Days 1 and 15: 0-6 hours post-dose

Study Arms (2)

Cohort 1: E6742 100 mg or Placebo

EXPERIMENTAL

Participants will receive E6742 100 milligram (mg) tablet or E6742-matched placebo tablet, orally, twice daily for up to 85 days.

Drug: E6742; Other: Placebo

Cohort 2: E6742 200 mg or Placebo

EXPERIMENTAL

Participants will receive E6742 200 mg tablets (two tablets of each 100 mg) or E6742-matched placebo tablets, orally, twice daily for up to 85 days.

Drug: E6742; Other: Placebo

Interventions

E6742 DRUG

E6742 tablet.

Cohort 1: E6742 100 mg or Placebo; Cohort 2: E6742 200 mg or Placebo

Placebo OTHER

E6742-matching placebo tablet.

Cohort 1: E6742 100 mg or Placebo; Cohort 2: E6742 200 mg or 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, 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

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 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
• Any history of 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (12)

Chukyo Hospital

Nagoya, Aichi-ken, Japan

Location

Daido Clinic

Nagoya, Aichi-ken, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan

Location

Hospital of the University of Occupational and Environmental Health

Kitakyushu, Fukuoka, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Location

St. Luke's International Hospital

Chuo-ku, Tokyo, Japan

Location

Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Tama Medical Center

Fuchū, Tokyo, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Tokyo, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Location

Related Publications (1)

• Tanaka Y, Kumanogoh A, Atsumi T, Ishii T, Tago F, Aoki M, Yamamuro S, Akira S. Safety, pharmacokinetics, biomarker response and efficacy of E6742: a dual antagonist of Toll-like receptors 7 and 8, in a first in patient, randomised, double-blind, phase I/II study in systemic lupus erythematosus. RMD Open. 2024 Sep 17;10(3):e004701. doi: 10.1136/rmdopen-2024-004701.

  PMID: 39289029 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: April 14, 2022
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (12)