Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) (LYNX)

Gilead Sciences

Status and phase: Terminated; Phase 1

Conditions: Cutaneous Lupus Erythematosus

Treatments: Drug: Placebo; Drug: Edecesertib; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04809623

GS-US-497-5888

2021-000204-38 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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, neuropsychiatric SLE, vasculitis etc.).
• History of malignancy.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups

Edecesertib

Experimental group

Description:

Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.

Treatment:

Drug: Standard of Care

Drug: Edecesertib

Placebo

Experimental group

Description:

Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.

Treatment:

Drug: Standard of Care

Drug: Placebo