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Lupus Erythematosus, SystemicPhase 1/2NCT05278663

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

A Phase 1/2 study testing E6742 in people with Lupus Erythematosus, Systemic, run by Eisai Co., Ltd. at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
E6742
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
12 sitesJapan
Study dates
14 Apr 2022to 4 Sep 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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 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)

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo

  • St. Luke's International Hospital

    Chuo-ku, Tokyo

  • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Tama Medical Center

    Fuchū, Tokyo

  • National Hospital Organization Kyushu Medical Center

    Fukuoka

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu, Fukuoka

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime

  • Chukyo Hospital

    Nagoya, Aichi-ken

  • Daido Clinic

    Nagoya, Aichi-ken

  • Hokkaido University Hospital

    Sapporo, Hokkaido

  • Tohoku University Hospital

    Sendai, Miyagi

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo

  • Osaka University Hospital

    Suita, Osaka

Other trials in Japan

About this study

Official title: 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

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).

Being tested
E6742, Placebo
Keywords
E6742
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E6742Drug

    E6742 tablet.

  • PlaceboOther

    E6742-matching placebo tablet.

Study groups in NCT05278663
Study groupRoleWhat they receive
Cohort 1: E6742 100 mg or PlaceboExperimentalParticipants will receive E6742 100 milligram (mg) tablet or E6742-matched placebo tablet, orally, twice daily for up to 85 days.
Receives: Drug: E6742; Other: Placebo
Cohort 2: E6742 200 mg or PlaceboExperimentalParticipants 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.
Receives: Drug: E6742; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

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

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

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

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2022
  2. Study start14 Apr 2022
  3. Primary completion4 Sep 2023
  4. Study completion4 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05278663
Sponsor's protocol ID
E6742-J081-101
Other IDs
jRCT2041210137
Status last verified
Apr 2023
First submitted
4 Mar 2022
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Publications

  • 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.

    PubMed 39289029

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing E6742 in people with Lupus Erythematosus, Systemic, run by Eisai Co., Ltd. at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Screening up to 28 days after the last dose of study drug at Day 85 (up to approximately 1 year 5 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05278663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.

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