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

NCT05966480 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Envudeucitinib

Oral tablet

DRUG

Placebo

Oral tablet

Sponsors & Collaborators

  • Alumis Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2026-07-01
Completion
2027-09-01
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05966480 on ClinicalTrials.gov