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New treatment option for Systemic Lupus Erythematosus
Official title A Study of E6742 in Participants With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07515014
What this study is testing
What is E6742?
E6742 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of the study is to demonstrate the efficacy based on dose response of E6742 compared with placebo as defined by the proportion of participants achieving a response using the British Isles Lupus Assessment Group (BILAG) based Composite Lupus Assessment (BICLA) with a low dose of oral corticosteroids (OCS) (prednisone or equivalent) at Week 24 in participants with systemic lupus erythematosus (SLE).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female adult, age \>=18 years (the minimum age may be different from 18 years in certain countries based on regional requirements) and \<=75...
- Diagnosed with SLE at least 6 months before the informed consent AND fulfill the 2019 EULAR/ACR classification criteria at Screening based on medical...
- At least BILAG-2004 category A in \>=1 organ system or BILAG-2004 category B in \>=2 organ systems at screening
- SLEDAI-2K score \>=6 points at Screening AND Clinical SLEDAI-2K score \>=4 points at Baseline
- Receiving at least one of the following treatments for SLE (if more than 1 treatment is used, all medications must be within the dosage defined in...
You likely can't join if
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] or human...
- 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 (IUD) or intrauterine hormone-releasing system (IUS)
- A contraceptive implant
See the full eligibility criteria
Who can join
- Male or female adult, age \>=18 years (the minimum age may be different from 18 years in certain countries based on regional requirements) and \<=75 years at the time of informed consent
- Diagnosed with SLE at least 6 months before the informed consent AND fulfill the 2019 EULAR/ACR classification criteria at Screening based on medical history
- At least BILAG-2004 category A in \>=1 organ system or BILAG-2004 category B in \>=2 organ systems at screening
- SLEDAI-2K score \>=6 points at Screening AND Clinical SLEDAI-2K score \>=4 points at Baseline
- Receiving at least one of the following treatments for SLE (if more than 1 treatment is used, all medications must be within the dosage defined in the protocol):
- OCS (\<=30 mg/day, prednisone or equivalent): The dosing regimen should be stable for at least 4 weeks before the first dose of study drug.
- Oral hydroxychloroquine (\<=400 mg/day), quinacrine (\<=200 mg/day): These medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should...
- Immunosuppressants: The following medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the...
- Mycophenolate mofetil (\<=3 g/day)
- Mycophenolate sodium (\<=2160 mg/day)
- Azathioprine (\<=200 mg/day)
- 6-mercaptopurine (\<=100 mg/day)
- Methotrexate (oral/subcutaneous/intramuscular) (\<=25 mg/week)
- Willing and able to provide written informed consent and comply with all aspects of the protocol
What rules you out
- 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...
- 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 (IUD) or intrauterine hormone-releasing system (IUS)
- A contraceptive implant
- Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral...
- Have a vasectomized partner with confirmed azoospermia
- Do not agree to use a highly effective method of contraception 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.
- 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...
- Drug-induced lupus erythematosus
- Active or unstable neuropsychiatric lupus (including but not limited to any condition defined by BILAG category A in neuropsychiatric organ system)
- Systemic autoimmune diseases other than SLE (eg, rheumatoid arthritis, Crohn's disease, systemic sclerosis [SSc], multiple sclerosis, polymyositis/ dermatomyositis [PM/DM]) that may affect the assessment of SLE...
- Sjögren's syndrome secondary to SLE
- Antiphospholipid antibody syndrome (APS) secondary to SLE
- Mixed Connective Tissue Disease (MCTD) not meeting diagnostic criteria for PM and SSc
- Any clinically significant symptom or organ impairment found by chest X-ray, ophthalmic examination, vital signs, or ECG finding at Screening or Baseline, laboratory test at Screening that in the opinion of the...
- Laboratory test results meeting any of the following criteria at Screening:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× upper limit of normal (ULN)
- Absolute neutrophil count (ANC) \<1,000 /mcL
- Platelet count \<50,000 /mcL
- Hemoglobin \<8.0 g/dL
- Renal impairment falling under any of the following criteria at Screening:
- Urine protein/creatinine ratio \>2.0 g/gCr
- Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) \<40 mL/min/1.73 m\^2
- Received vaccination within 2 weeks before the first dose of study drug (4 weeks before in case of live/ live attenuated vaccines)
- Currently or previously receiving gene therapy for SLE (eg, CAR-T cell therapy)
- Currently enrolled in another clinical study or used any investigational drug or device (including E6742) within 28 days (or 5× the half-life, whichever is longer) before obtaining informed consent
- Any history of the following clinically significant infections:
- Infections requiring hospitalization or intravenous antibiotics, or administration of antiviral drugs, within 4 weeks before the first dose of study drug
- Active tuberculosis
- Any findings indicating a history of tuberculosis on chest X-ray at Screening
- Positive or repeated hold (indeterminate or intermediate) in tuberculosis test (Interferon-γ release assays) at Screening
- A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 millisecond (ms) according to central reading at Screening. If the QTcF machine read is greater than 440 ms on the first single...
- A prolonged QTcF interval (mean QTcF \>450 ms) as demonstrated by triplicated ECGs at Baseline. Has any risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome) or the use...
- Hypersensitivity to the study drug, drug product chemical derivate or any of the excipients at Screening
- Any history of or concomitant medical condition that in the opinion of the investigators would compromise the participants ability to safely complete the study
- Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without...
- Positive on test at Screening for human immunodeficiency virus (HIV)
- Positive on test at Screening for hepatitis B virus (HBV) with a detectable (eg, hepatitis B virus surface [HBs] antigen reactive, HBs antibody, hepatitis B virus core [HBc] antibody, HBV deoxyribose nucleic acid (DNA))...
- 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 or concurrent of 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)
- Assessed to be inappropriate for clinical study by investigators
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shantou, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Yichang, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Jiujiang, Jiangxi, China
- Nanchang, Jiangxi, China
- Pingxiang, Jiangxi, China
- Changchun, Jilin, China
- Taiyuan, Shanxi, China
- Hangzhou, Zhejiang, China
- Nagoya, Aichi-ken, Japan
- Toyoake, Aichi-ken, Japan
- Kitakyushu, Fukuoka, Japan
- Sapporo, Hokkaidô, Japan
+ 17 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shantou, Guangdong, China; Nanning, Guangxi, China; Guiyang, Guizhou, China and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.