Phase 2 Trial of E6742 Tablets for Treating Adults with Systemic Lupus Erythematosus Up to Age 75

What this Trial Is About

Researchers are evaluating the effectiveness of E6742 tablets in adults aged 18 to 75 years with systemic lupus erythematosus SLE. This Phase 2 trial aims to compare different doses of E6742 with a placebo by measuring the proportion of participants who achieve a response using the BILAG-based Composite Lupus Assessment BICLA while on a low dose of oral corticosteroids at Week 24. The study focuses on improving disease control in SLE patients under stable treatment conditions. Participants will be randomly assigned to one of four groups receiving either placebo or one of three different doses of E6742 oral tablets. The treatment period lasts 24 weeks, during which participants continue their standard SLE treatments at stable doses. The study includes careful monitoring of responses and safety through various assessments, including laboratory tests and clinical evaluations. During the trial, participants will undergo regular evaluations to measure disease activity, side effects, and drug levels. Assessments include the BILAG-2004, SLEDAI-2K, electrocardiograms, ophthalmic exams, chest X-rays, and patient-reported outcomes. Safety is monitored throughout the 52-week period, with detailed tracking of adverse events and laboratory parameters. Participants will be involved in scheduled visits and assessments to understand the drugs effects and tolerability over time.

A Study of E6742 in Participants With Systemic Lupus Erythematosus