ACTIVE_NOT_RECRUITING

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

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Conditions

Cutaneous Lupus Erythematosus (CLE)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE. Information on what is happening in the body relating to CLE, how the body processes, is affected by and responds to the study drug, and any study drug side effects will also be collected in this study.

Official Title

A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)

Quick Facts

Study Start:2023-04-17
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05629208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Either fulfill European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) and/or have biopsy confirmed Cutaneous Lupus Erythematosus (CLE) at any time.
  2. * Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas.
  3. * Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening.
  4. * Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points.
  5. * Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments.
  6. * Topical corticosteroids or topical calcineurin inhibitors.
  7. * Oral corticosteroids.
  8. * Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).
  9. * Individuals willing to comply with all study visits and assessments.
  1. * Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localized acute CLE involving only 1 distinct body area at screening and Day 1.
  2. * Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis).
  3. * Presence of active skin conditions other than cutaneous lupus that may interfere with assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-induced lupus).
  4. * Meet protocol-specified infection or lab criteria.
  5. * Any active infection that is clinically significant (per investigator judgment).
  6. * Any history of clinically significant liver disease.
  7. * Significant cardiovascular disease.

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

ARENSIA Exploratory Medicine, LLC
Phoenix, Arizona, 85015
United States
Center for Dermatology Clinical Research Inc.
Fremont, California, 94538
United States
University of Colorado, Barbara Davis Center, Center for Clinical Research
Aurora, Colorado, 80045
United States
Yale Center for Clinical Investigation (YCCI)
New Haven, Connecticut, 06510
United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
United States
Reliant Medical Research
Miami, Florida, 33165
United States
HMD Research LLC
Orlando, Florida, 32819
United States
Emory University School of Medicine
Atlanta, Georgia, 30303
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
United States
Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, 19104
United States
Gulf Bank Medical Center
Houston, Texas, 77037
United States
Clinical Investigations of Texas
Plano, Texas, 75075
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-17
Study Completion Date2026-01

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cutaneous Lupus Erythematosus (CLE)