STATUS Terminated

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Terminated

GILEAD STUDY ID

GS-US-497-5888

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

April 05, 2024

Clinicaltrials.gov ID

NCT04809623

EudraCT ID

2021-000204-38

STUDY DOCUMENTS

View study documents

OVERVIEW

A Randomized, Blinded, Placebo-Controlled, Phase 1b Study of GS-5718 in Subjects With Cutaneous Lupus Erythematosus (CLE) (LYNX)

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

Study details

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.