A Phase 2 interventional study of E6742 and Placebo in Systemic Lupus Erythematosus, sponsored by Eisai Co., Ltd.. Recruiting at 54 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Eisai Co., Ltd. · Phase 2, Interventional, and Treatment
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).
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 256 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Eisai Co., Ltd. is the lead sponsor of 152 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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):
: 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 first dose
Exclusion Criteria
Females of who:
Within 28 days before study entry, did not use a highly effective method of , which includes any of the following:
Systemic 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 pathology at Screening. The participants with the following diseases may be included in the study
Laboratory test results meeting any of the following criteria at Screening:
Renal impairment falling under any of the following criteria at Screening:
Any history of the following clinically significant infections:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Placebo
Drug: E6742
Drug: E6742
Drug: E6742
E6742 oral tablets.
Placebo oral tablets.
Percentage of Participants who Achieve a BICLA Response with Low Dose of OCS (Prednisone or Equivalent) at Week 24
The BICLA is a composite index used to assess disease activity in SLE. A BICLA response is defined as reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; no BILAG-2004 worsening in other organ systems, as defined by greater than or equal to (\>=1) new BILAG-2004 A or \>= 2 new BILAG-2004 B; no worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) as defined as an increase from baseline of greater than (\>) 0 points in SLEDAI-2K; no worsening from baseline in participants lupus disease activity defined by an increase \>=0.30 points on a 3-point Physician Global Assessment Visual Analogue Scale (PGA VAS); and no treatment failure.
Time frame: At Week 24
Percentage of Participants who Achieve an SLE Responder Index- 4 (SRI-4) Response with Low Dose of OCS (Prednisone or Equivalent) at Week 24
The SRI-4 responder will be defined as a participant meeting all of the following criteria: at least a 4-point reduction from baseline in SLEDAI-2K score; no new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items compared to baseline using BILAG-2004; no worsening from baseline in participants lupus disease activity defined by an increase \>=0.30 points on a 3-point PGA VAS.
Time frame: At Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent SAEs
Time frame: From baseline up to 52 weeks
Number of Participants With Clinically Significant Changes in Laboratory Parameters
Laboratory parameters will include hematology, blood chemistry and urinalysis. Any clinically significant change in laboratory parameters will be determined at the investigator's discretion.
Time frame: From baseline up to 52 weeks
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs will include measurement of body temperature, respiratory rate, sitting blood pressure and pulse rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.
Time frame: From baseline up to 52 weeks
Frequency and Percentage of Abnormal Findings in 12-lead Electrocardiogram (ECG) Parameters
Time frame: From baseline up to 52 weeks
Frequency and Percentage of Abnormal Findings in Ophthalmic Examination
Time frame: From baseline up to Week 48
Frequency and Percentage of Abnormal Findings in Chest X-rays
Time frame: From baseline up to Week 48
Percentage of Participants with Low Dose of OCS (Prednisone or Equivalent) at Week 24
Time frame: At Week 24
Change From Baseline in SLEDAI-2K
SLEDAI-2K is a scale that stratifies severity of disease activity. It comprises 24 weighted items (16 clinical, 8 laboratory), with individual scores ranging from 1 to 8 and a total score from 0 to 105. Higher scores indicate greater disease activity and more severe organ involvement.
Time frame: Baseline, at Week 24
Change From Baseline in BILAG-2004
The BILAG-2004 is a validated instrument for assessing systemic lupus erythematosus (SLE) disease activity. It evaluates 97 clinical and laboratory items across one systemic symptom and eight organ systems (mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, hematological). Manifestations in the prior 4 weeks are scored on a 5-point scale (0-4), and each organ/system is categorized into five levels (A-E), ranging from severe activity (A) to never involved (E).
Time frame: Baseline, at Week 24
Change From Baseline in PGA
The PGA is a widely used scale in clinical trials to measure overall disease severity as assessed by the physician. It is evaluated on a 10-centimeter (cm) VAS scored from 0 to 3. An increase of \>=1 point with a score 2.5 indicates mild to moderate worsening, while a score \>2.5 indicates severe worsening. Higher PGA scores reflect greater disease activity.
Time frame: Baseline, at Week 24
Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
The CLASI is an assessment scale used to evaluate the disease activity of cutaneous lupus erythematosus (CLE), and it is also commonly used to assess cutaneous manifestation in SLE. It consists of an activity score, an index of the acute phase, and damage score, an index of the chronic phase. The activity score is composed of 4 items: Erythema, scale/hypertrophy, mucous membrane involvement, and alopecia, with a total range of 0-70. The damage score consists of 3 items: Dyspigmentation, scarring/atrophy/panniculitis and scarring of the scalp, with a total range of 0-56. Higher values indicate more severity.
Time frame: Baseline, at Week 24
Change From Baseline in Joint Count
Time frame: Baseline, at Week 24
Change From Baseline in Systemic Lupus International Collaborating Clinics/ American College of Rheumatology (SLICC/ACR) Damage Index)
The SLICC/ACR Damage Index is an index to assess organ damage in SLE participants and is composed of 12 evaluation items for organ systems. Irreversible lesions occurring since the onset of SLE and present for at least 6 months are evaluated. The sum of the scores for each dimension represents the degree of impairment for that individual participant. Higher scores indicate more disease severity.
Time frame: Baseline, at Week 24
Change From Baseline in Autoantibody
Time frame: Baseline, at Week 24
Change From Baseline in Complements (C3 and C4)
Time frame: Baseline, at Week 24
Change From Baseline in Lupus-Patient-Reported Outcomes (Lupus-PRO)
The Lupus-PRO is a validated, SLE specific quality of life instrument consisting of 43 questions. This PRO comprehensively measures a variety of concerns relevant to lupus participants, and the impact of lupus and its treatment on their health-related quality of life (HRQOL), as well as non-health-related quality of life (non-HRQOL).
Time frame: Baseline, at Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The FACIT-F is a validated 13-item questionnaire assessing fatigue, with each item rated on a 4-point Likert scale: 0 (Not at all) to 4 (Very much). Total scores range from 0 to 52, with higher scores indicating less fatigue and better quality of life
Time frame: Baseline, at Week 24
Percentage of Participants who Achieve a BICLA Response
The BICLA is a composite index used to assess disease activity in SLE. A BICLA response is defined as reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; no BILAG-2004 worsening in other organ systems, as defined by \>=1 new BILAG-2004 A or \>= 2 new BILAG-2004 B; no worsening from baseline in SLEDAI-2K as defined as an increase from baseline of \>0 points in SLEDAI-2K; no worsening from baseline in participants lupus disease activity defined by an increase \>=0.30 points on a 3-point PGA VAS; and no treatment failure.
Time frame: At Week 24
Percentage of Participants who Achieve a SLE Responder Index- X (SRI-X) Response
The SRI-X responder will be defined as a participant meeting all of the following criteria: at least a X-point reduction from baseline in SLEDAI-2K score; no new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items compared to baseline using BILAG-2004; no worsening from baseline in participants lupus disease activity defined by an increase \>=0.30 points on a 3-point PGA VAS.
Time frame: At Week 24
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS)
LLDAS responder is defined as meeting all of the following criteria: SLEDAI-2K \<=4 points, with no activity in major organ systems (renal, central nervous system \[CNS\], cardiopulmonary, vasculitis, fever); no new lupus disease activity compared with the previous assessment; safety of Estrogen in Systemic Lupus Erythematosus National Assessment (SELENA) - SLEDAI PGA \<=1 point; current prednisone (or equivalent) dose \<=7.5 mg/day; and standard maintenance doses of immunosuppressive drugs and approved biological agents.
Time frame: At Week 24
Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) Remission
DORIS responder is defined as meeting all of the following criteria: clinical SLEDAI (excluding serology) = 0; PGA VAS score (scale 0-3) less than (\<) 0.5; Prednisone (or equivalent) dose less than or equal to (\<=) 5 mg/day, and stable antimalarials, immunosuppressives, and biologics.
Time frame: At Week 24
Duration in a LLDAS
LLDAS responder is defined as meeting all of the following criteria: SLEDAI-2K \<=4 points, with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, fever); no new lupus disease activity compared with the previous assessment; safety of Estrogen in SELENA-SLEDAI PGA \<=1 point; current prednisone (or equivalent) dose \<=7.5 mg/day; and standard maintenance doses of immunosuppressive drugs and approved biological agents.
Time frame: Week 24
Duration in a DORIS Remission
DORIS responder is defined as meeting all of the following criteria: clinical SLEDAI (excluding serology) = 0; PGA VAS score (scale 0-3) \< 0.5; Prednisone (or equivalent) dose \<=5 mg/day, and stable antimalarials, immunosuppressives, and biologics.
Time frame: Week 24
Time to First Response of BICLA
The BICLA is a composite index used to assess disease activity in SLE. A BICLA response is defined as reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; no BILAG-2004 worsening in other organ systems, as defined by \>=1 new BILAG-2004 A or \>= 2 new BILAG-2004 B; no worsening from baseline in SLEDAI-2K as defined as an increase from baseline of \>0 points in SLEDAI-2K; no worsening from baseline in participants lupus disease activity defined by an increase \>=0.30 points on a 3-point PGA VAS; and no treatment failure.
Time frame: Week 24
Time to First Response of SRI-4
The SRI-4 responder will be defined as a participant meeting all of the following criteria: at least a 4-point reduction from baseline in SLEDAI-2K score; no new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items compared to baseline using BILAG-2004; no worsening from baseline in participants lupus disease activity defined by an increase \>=0.30 points on a 3-point PGA VAS.
Time frame: Week 24
Percentage of Participants with mild/Moderate, or Severe Flares Assessed by Hybrid SELENA-SLEDAI Flare Index
A mild/moderate flare is defined as change in SLEDAI-2K instrument score of 3 points/more (but not to \>12); new or worse discoid, photosensitive, profundus, cutaneous vasculitis, bullous lupus; nasopharyngeal ulcers; pleuritis; pericarditis; arthritis; or fever due to SLE; increase in prednisone requirement, but not to \>0.5 mg/kg/day; addition of an non-steroidal anti-inflammatory drugs (NSAID) or hydroxychloroquine for SLE activity; \>=1.0 increase in PGA score, but not to \>2.5. A severe flare is defined as change in SLEDAI-2K instrument score \>12 points; new or worse central nervous system SLE; vasculitis; nephritis; myositis; platelets \<60,000 /microliter (mcl); or hemolytic anemia with hemoglobin \<7.0 gram per deciliter (g/dL) or decrease in hemoglobin \>3.0 g/dL; increase in prednisone dose to \>0.5 mg/kg/day; new requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity; hospitalization for SLE activity; increase in PGA score to \>2.5.
Time frame: At Week 24
Percentage of Participants with Mild, Moderate, or Severe Flares Assessed by BILAG- 2004 Flare
A mild flare is defined as appearance of B score due to new or worsening in 1 or more organ system OR appearance of C score due to new or worsening in 3 or more organ systems. A moderate flare is defined as appearance of B score due to new or worsening in 2 or more organ systems. A severe flare is defined as appearance of A score due to new or worsening in any organ system.
Time frame: At Week 24
Percentage of Participants who Achieve a CLASI-50 Response
CLASI-50 response was defined as a 50% improvement from baseline in CLASI-A score.
Time frame: At Week 24
Plasma concentrations of E6742
Time frame: Up to 24 weeks
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Studies of the drug tested here: E6742
Lupus Erythematosus, Systemic →