Phase 2 Placebo-controlled Study to Assess the Safety, Efficacy, and PK of ESK-001 in SLE

Trial details

Who runs it

Alumis Inc.

Trial code

EU 2022-502105-15-00

Record updated

2026. június 16.

Original description

• Part A: To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at week 48 between doses of ESK-001 and placebo • Part B: To assess the safety and tolerability of ESK-001 at a single dose.Read full original descriptionShow less

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

• Part A: To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at week 48 between doses of ESK-001 and placebo • Part B: To assess the safety and tolerability of ESK-001 at a single dose.

Inclusion: Able and willing to provide written informed consent (signed and dated) to participate in this study and comply with all requirements in the study protocol; Males or females, age 18 to 70 years, inclusive, at the time of informed consent; Body mass index 18 to 40 kg/m2 and total body weight >40 kg (88 lbs); Adequate peripheral venous access; Diagnosed with SLE ≥6 months prior to screening, fulfills the 2019 European League Against Rheumatism (EULAR)/ACR criteria at the time of screening; Clinical SLEDAI-2K score ≥4 points with skin involvement prior to first administration of study drug; Currently receives at least 1 of the following: • A stable dose of oral corticosteroid as defined in the protocol • And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine), • And/or no more than 1 of the conventional DMARDS as detailed in the protocol; Negative serum ß-human chorionic gonadotropin (ß-hCG) test at screening (women of childbearing potential [WOCBP] only) Please see the protocol for the full list of inclusion criteria.

Exclusion: Receipt of B cell-depleting therapy <6 months prior to signing the ICF or, if therapy was administered >6 months prior to signing the ICF, absolute B cell within the limits as defined in the protocol; Has received any therapeutic agent targeted to IL-12, IL-17, or IL-23 within 6 months or any tumor necrosis factor alpha inhibitor(s) within 12 weeks of prior to signing the ICF; Has received JAK inhibitors (eg, baricitinib, tofacitinib) or TYK2 inhibitors within 12 weeks of prior to signing the ICF; Any of the following: • Currently active, clinically significant infection of any kind • Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) within 8 weeks prior to signing the ICF • Any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF Please see the protocol for the full list of exclusion criteria; History of or current diagnosis of catastrophic antiphospholipid syndrome within 12 months prior to signing the ICF; History of any recurrent non-SLE disease that required treatment with oral or parenteral Corticosteroids as defined in the protocol; Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF; Drug-induced SLE or other autoimmune diseases that, in the opinion of the Investigator, are likely to confound efficacy assessments; Current disease other than SLE that, in the opinion of the Investigator, is likely to interfere with SLE disease activity assessments; Pregnant, lactating, or planning to get pregnant during the study period and for 1 month after study completion or discontinuation; Patients with QTcF >450 msec on ECG at screening; Active, proliferative lupus nephritis that in the Investigator’s opinion may require treatment not allowed by the protocol; Active severe or unstable neuropsychiatric SLE as defined in the protocol.

EU CTIS 2022-502105-15-00