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Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT04809623•Gilead Sciences

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (5)

Wallace Rheumatic Studies Center, LLC

Beverly Hills, California, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Dawes Fretzin Clincial Research Group, LLC

Indianapolis, Indiana, United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

Metroplex Clinical Research Center

Dallas, Texas, United States

Key Dates

Start Date

September 1, 2021

Primary Completion Date

October 18, 2022

Completion Date

October 18, 2022

Last Updated

April 5, 2024

Enrollment

ACTUAL participants

Conditions

Cutaneous Lupus Erythematosus

Interventions

Edecesertib

DRUG

Placebo

DRUG

Standard of Care

DRUG

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

NCT06875960

Systemic Lupus Erythematosus (SLE)Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

View study

TERMINATEDPHASE2

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

NCT05629208

Cutaneous Lupus Erythematosus (CLE)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

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

Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

Study of M5049 in CLE and SLE Participants

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