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
Qualifiers
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
Treatments tested in this trial
- E6742
- Placebo
Treatment groups
256 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov