Study of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)
- Conditions
- Cutaneous Lupus Erythematosus (CLE)MedDRA version: 21.1Level: PTClassification code: 10056509Term: Cutaneous lupus erythematosus Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2022-501523-24-00
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
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. Note: Other protocol defined Inclusion criteria may apply.
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 Exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of GS-5718 versus PTM in reducing skin disease activity for participants with CLE with or without SLE.;Secondary Objective: To evaluate the efficacy of GS-5718 versus PTM in reducing skin disease activity for participants with CLE with or without SLE., To evaluate the safety and tolerability of GS-5718 in participants with CLE with or without SLE., To characterize the PK of GS-5718 in participants with CLE with or without SLE.;Primary end point(s): Percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at Week 12.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Proportion of participants with Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) score of 0 or 1 at Week 12.;Secondary end point(s):Incidence of treatment-emergent adverse events (TEAEs).;Secondary end point(s):Incidence of treatment-emergent serious adverse events (TESAEs).;Secondary end point(s):Incidence of treatment-emergent laboratory abnormalities.;Secondary end point(s):PK characteristics of GS-5718