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Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus — LUMUS  

SLE Clinical Trial

Official title:
A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Dose Levels of ESK-001 in Adult Patients With Systemic Lupus Erythematosus

Clinical Trial Summary

The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.

Clinical Trial Description

This study will consist of a 5 week screening period, 48 week treatment period, and a 4 week follow up period for a total of 57 weeks. Each participant will be randomized to receive ESK-001 or placebo for 48 weeks. An open label extension study will be available for those patients who complete the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05966480
Study type Interventional
Source Alumis Inc
Contact Central Recruiting
Phone (+1) 650-538-2502
Email clinicaltrials@alumis.com
Status Recruiting
Phase Phase 2
Start date June 26, 2023
Completion date December 1, 2025
View Details
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