Study of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)

  • End date
    Jan 29, 2023
  • participants needed
  • sponsor
    Gilead Sciences
Updated on 22 September 2021


The primary objective of this study is to evaluate the safety and tolerability of GS-5718 in participants with Cutaneous Lupus Erythematosus (CLE) with or without Systemic Lupus Erythematosus (SLE).

Condition Subacute cutaneous lupus erythematosus
Treatment Placebo, GS-5718
Clinical Study IdentifierNCT04809623
SponsorGilead Sciences
Last Modified on22 September 2021


Yes No Not Sure

Inclusion Criteria

Either fulfill Image result for eular medical abbreviation The European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for SLE or have biopsy-proven CLE
Must have active acute cutaneous lupus erythematosus (ACLE)/ subacute cutaneous lupus erythematosus (SCLE); individuals with mixed skin presentations of lupus skin disease (including DLE) are allowed to enter
Cutaneous LE Disease Area and Severity Index (CLASI) activity score of 6 during screening and Day 1, excluding the alopecia component
Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and willingness to undergo skin biopsy at 2 time points
Protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents for the treatment of CLE/SLE (eg, antimalarials, methotrexate (MTX), or other conventional synthetic disease-modifying antirheumatic drug (csDMARDs)) must maintain stable dose(s) for 60 days prior to randomization through Week 4 of the study

Exclusion Criteria

Dermatologic disease other than cutaneous manifestations of SLE or CLE that may interfere with assessment of lupus-specific skin lesions
Ongoing or active clinically significant bacterial, fungal or viral infection
History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
Uncontrolled health conditions including highly active SLE (e.g. lupus nephritis, neuropsychiatric SLE, vasculitis etc.)
History of malignancy
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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