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

Launched by GILEAD SCIENCES · Nov 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called edecesertib to see how it can help people with Cutaneous Lupus Erythematosus (CLE), a skin condition related to lupus. The researchers want to understand how the drug works in the body, how it affects CLE, and what side effects it might cause. The trial is currently looking for participants between the ages of 6 and 93 who have active CLE. To be eligible, individuals must have a specific level of skin involvement and must have not responded well to certain previous treatments for lupus.

Participants will need to attend several study visits and undergo skin tests, including a small skin biopsy to help assess the condition. The study aims to gather important information about how effective edecesertib is for treating CLE. It’s important for potential participants to be aware that they should not have certain other skin conditions or serious health issues, as these could affect their ability to join the trial. If you or someone you know is interested in participating, it’s a good idea to discuss it with a healthcare provider to see if it’s a suitable option.

Gender

ALL

Eligibility criteria

• 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 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.