Safety, Efficacy, and Pharmacokinetics Dose Levels of ESK-001 in Adult Patient with Lupus
Research type
Research Study
Full 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.
IRAS ID
1008021
Contact name
Joel Selcher
Contact email
Sponsor organisation
Alumis Inc
Research summary
In this study,participants will be given an investigational drug called called ESK 001. ESK 001 is not approved by any regulatory authority for the treatment of Lupus.
ESK-001 is being developed as an oral treatment for patients with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE). ESK-001 is a tyrosine kinase 2(TYK2 ) inhibitor that reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-α.
ESK-001 has the potential to reduce SLE disease activity by interfering with pro-inflammatory pathways known to be involved in the pathogenesis of SLE. Because of its high degree of specificity for TYK2, ESK-001 is expected to show fewer adverse events associated with inhibition of related tyrosine kinases, such as JAK1-3. In ESK-001 works by blocking certain proteins in your immune system which can help to reduce lupus related symptoms. ESK-001.
The primary goal 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.
This study is divided into 3 periods: a screening period, a treatment period, and a follow up period.REC name
London - Central Research Ethics Committee
REC reference
23/LO/0572
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion