Overview

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

Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Criteria
Key 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

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,
neuropsychiatric SLE, vasculitis etc.)

- History of malignancy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.