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

Prior treatment

• 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

Other illness

• 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.

Other

• 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

• 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.