Status:
TERMINATED
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Lead Sponsor:
Gilead Sciences
Conditions:
Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04809623
Start Date
September 1 2021
End Date
October 18 2022
Last Update
April 5 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Wallace Rheumatic Studies Center, LLC
Beverly Hills, California, United States, 90211
2
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
3
Dawes Fretzin Clincial Research Group, LLC
Indianapolis, Indiana, United States, 46250
4
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28210