Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

Open to people ages 18-75

• Either fulfill European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) and/or have biopsy confirmed Cutaneous Lupus Erythematosus (CLE) at any time.
• Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas.
• Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening.
• Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points.
• Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments.
  • Topical corticosteroids or topical calcineurin inhibitors.
  • Oral corticosteroids.
  • Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).
• Individuals willing to comply with all study visits and assessments.

• Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localized acute CLE involving only 1 distinct body area at screening and Day 1.
• Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis).
• Presence of active skin conditions other than cutaneous lupus that may interfere with assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-induced lupus).
• Meet protocol-specified infection or lab criteria.
  • Any active infection that is clinically significant (per investigator judgment).
• Any history of clinically significant liver disease.
• Significant cardiovascular disease.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.