Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) (NCT05629208) | Clinical Trial Compass
TerminatedPhase 2
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Stopped: Sponsor Decision
United States20 participantsStarted 2023-04-17
Plain-language summary
The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE. Information on what is happening in the body relating to CLE, how the body processes, is affected by and responds to the study drug, and any study drug side effects will also be collected in this study.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localize…
What they're measuring
1
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12