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
Brief description of study
Overall Design: This is a Phase 2, multicenter, multinational, randomized, double blind, placebo controlled study to evaluate the safety, efficacy, PK, and PD of 3 dose levels of ESK 001 (20 mg once daily [QD], 40 mg [taken as 20 mg twice daily (BID)], and 80 mg [taken as 40 mg twice daily (BID)] in patients with moderately to severely active, autoantibody positive SLE while receiving standard of care (SOC) treatment in adult patients aged 18 to 70 years of age. The purpose 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. Study details include the following: • Randomization will be stratified using the SLEDAI 2K score at screening (<10 points vs =10 points), corticosteroid dose on Day 1 (<10 mg/day prednisone equivalent vs =10 mg/day) and IGS score (high vs low). • The study includes a protocol defined corticosteroid taper. • Efficacy assessments include SLEDAI 2K, BILAG 2004, PGA VAS, CLASI, tender and swollen joint counts • Patient reported outcome (PRO) measures include SF 36 v.2 acute, Lupus QoL, Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue questionnaire and Patient Global Assessment (PtGA). • Safety assessments include AE monitoring, clinical laboratory tests, vital signs, ECGs, and physical examinations. • Observed concentration time data will mainly be used for modeling and simulation purposes. PK parameters include average maximum observed concentration (Cmax) and time to Cmax (Tmax); the trough plasma concentrations right before dosing (Ctrough) of ESK 001 may be determined as data permits. • Exploratory PD and biomarker assessments include blood based transcriptomic, proteomic, and other TYK2 relevant and disease relevant markers.
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