NCT05966480

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Alumis Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• SLE

Interventions

Type	Name	Description
DRUG	Envudeucitinib	Oral tablet
DRUG	Placebo	Oral tablet

Timeline

• Start date: 2023-06-26
• Primary completion: 2026-07-01
• Completion: 2027-09-01
• First posted: 2023-07-28
• Last updated: 2026-04-08

Locations

169 sites across 21 countries: United States, Argentina, Bulgaria, Chile, Colombia, Croatia, Denmark, Georgia, Germany, Hungary, India, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study