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

The purpose of this study is to assess the effectiveness and safety of an investigational drug (ESK-001) in adult patients with systemic lupus erythematosus (SLE), when compared to a placebo.

There will be 4 study groups. If you are eligible and agree to participate, you will be randomly assigned to 1 of 4 arms:

  • Arm 1 will receive the study drug ESK-001 at 20 mg
  • Arm 2 will receive the study drug ESK-001 at 40 mg
  • Arm 3 will receive the study drug ESK-001 at 80 mg
  • Arm 4 will receive the Placebo
This study is "double-blind," meaning neither the patients nor the doctors will know who is getting what until after the study is done.

Clinical Study Identifier: s23-00356
Principal Investigator: David H. Goddard.

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