Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) (NCT04809623) | Clinical Trial Compass
TerminatedPhase 1
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Stopped: Sponsor decision to terminate study.
United States3 participantsStarted 2021-09-01
Plain-language summary
The primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly GS-5718) in participants with cutaneous lupus erythematosus (CLE) with or without systemic lupus erythematosus (SLE).
Who can participate
Age range18 Years – 75 Years
SexALL
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Key Inclusion Criteria:
* Either fulfill the European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) or have biopsy-proven cutaneous lupus erythematosus (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.
* CLE 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.
Key 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, neuropsychia…
What they're measuring
1
Percentage of Participants Who Experienced Treatment-emergent Adverse Events
Timeframe: First dose date up to 4 weeks plus 28 days
2
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Timeframe: First dose date up to 4 weeks plus 28 days