Study Details

PROTOCOL 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).

Participation Requirements

Age

18 Years - 75 Years

Sex

All

Healthy Volunteers

Medical Condition

Cutaneous Lupus Erythematosus

Gender

N/A

Date

September 2021 - October 2022

Study Type

Interventional

Study Phase

Phase 1

Product

Edecesertib, Placebo, Standard of Care

Eligibility Information

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.

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.

Locations

Locations (5)

Wallace Rheumatic Studies Center, LLC

Beverly Hills, California, United States, 90211

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States, 33765

Dawes Fretzin Clincial Research Group, LLC

Indianapolis, Indiana, United States, 46250

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States, 28210

Metroplex Clinical Research Center

Dallas, Texas, United States, 75231

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

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