Clinical trial NCT05629208: Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cutaneous Lupus Erythematosus (CLE)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

* 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.
* Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas.
* 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.
* 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.
* Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments.

  * Topical corticosteroids or topical calcineurin inhibitors.
  * Oral corticosteroids.
  * Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).
* Individuals willing to comply with all study visits and assessments.

Key Exclusion Criteria:

* 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.
* Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis).
* 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).
* Meet protocol-specified infection or lab criteria.

  * Any active infection that is clinically significant (per investigator judgment).
* Any history of clinically significant liver disease.
* Significant cardiovascular disease.

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

Primary outcomes:
measure: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12
timeFrame: Week 12
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to 12 weeks plus 30 days
measure: Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)
timeFrame: First dose date up to 12 weeks plus 30 days
measure: Percentage of Participants Experiencing Laboratory Abnormalities
timeFrame: First dose date up to 12 weeks plus 30 days
measure: Plasma Concentration of Edecesertib
timeFrame: Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: ARENSIA Exploratory Medicine, LLC
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research Inc.
state: California
city: La Jolla
country: United States
facility: UCSD Perlman Medical Offices
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado, Barbara Davis Center, Center for Clinical Research
state: Colorado
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation (YCCI)
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New York
country: United States
facility: Columbia University Medical Center- Herbert Irving Pavilion
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Philadelphia
country: United States
facility: Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Gulf Bank Medical Center
state: Texas
city: Plano
country: United States
facility: Clinical Investigations of Texas
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research - Red Oak
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze, Dermatovenerologická klinika
city: Praha
country: Czechia
facility: Kožní ambulance Fialová, s.r.o.
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Klinik für Dermatologie, Allergologie und Venerologie Allergie Centrum
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg Klinik fur Dermatologie und Venerologie
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE) - Haus 10
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Granollers
country: Spain
facility: Hospital General de Granollers
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: