Phase 2 Placebo-controlled Study to Assess the Safety, Efficacy, and PK of ESK-001 in SLE
- Conditions
- Systemic lupus erythematosusMedDRA version: 21.1Level: PTClassification code: 10042945Term: Systemic lupus erythematosus Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-502105-15-00
- Lead Sponsor
- Alumis Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 390
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.
Pregnant, lactating, or planning to get pregnant during the study period and for 1 month after study completion or discontinuation, 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., Patients with QTcF >450 msec on ECG at screening, Drug-induced SLE or other autoimmune diseases that, in the opinion of the Investigator, are likely to confound efficacy assessments, Active, proliferative lupus nephritis that in the Investigator’s opinion may require treatment not allowed by the protocol, Current disease other than SLE that, in the opinion of the Investigator, is likely to interfere with SLE disease activity assessments., Active severe or unstable neuropsychiatric SLE as defined in the protocol, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect on disease activity between doses of ESK-001 and placebo at Week 48 by the measure described in Protocol Section 2 Study Objectives and Endpoints”.;Secondary Objective: To assess the safety and tolerability of multiple dose levels of ESK-001 and various other assessments and comparisons as described in Protocol Section 2 Study Objectives and Endpoints”.;Primary end point(s): The composite endpoint defined by meeting all of the criteria as described in Protocol Section 2 Study Objectives and Endpoints”.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):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”.