A Study of E6742 in Participants With Systemic Lupus Erythematosus
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEisai Co., Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Total abstinence (if it is their preferred and usual lifestyle)
An intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
A contraceptive implant
Trial design
Design model
Parallel
Treatments tested in this trial
E6742
DrugE6742 oral tablets.
Placebo
Other interventionPlacebo oral tablets.
Treatment groups
256 Participants
are divided into 4 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: E6742 Dose AExperimental treatment 1 intervention
Group C: E6742 Dose BExperimental treatment 1 intervention
Group D: E6742 Dose CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 24Secondary outcomes
1
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 242
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent SAEs
Time frame
From baseline up to 52 weeks3
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 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov