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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502105-15-00

Acronym

ESK-001-010

Enrollment

136

Registered

2023-08-28

Start date

2023-10-20

Completion date

Unknown

Last updated

2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus

Brief summary

The composite endpoint defined by meeting all of the criteria as described in Protocol Section 2 “Study Objectives and Endpoints”.

Detailed description

Incidence of treatment-emergent AEs (TEAEs) and SAEs, vital signs, physical examination, 12-lead ECG, and clinical laboratory tests (hematology, clinical chemistry, urinalysis); other measurements and composite endpoints as described in Protocol Section 2 “Study Objectives and Endpoints”.

Interventions

DRUGESK-001

DRUGPlacebo

DRUGtablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The composite endpoint defined by meeting all of the criteria as described in Protocol Section 2 “Study Objectives and Endpoints”.	—

Secondary

Measure	Time frame
Incidence of treatment-emergent AEs (TEAEs) and SAEs, vital signs, physical examination, 12-lead ECG, and clinical laboratory tests (hematology, clinical chemistry, urinalysis); other measurements and composite endpoints as described in Protocol Section 2 “Study Objectives and Endpoints”.	—

Countries

Bulgaria, Croatia, Denmark, Germany, Hungary, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026