Cutaneous Lupus Erythematosus (CLE)
Conditions
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.
Interventions
DRUGEdecesertib
Tablets administered orally
DRUGEdecesertib Placebo
Tablets administered orally
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 | Baseline, Week 12 | The CLASI is a standardized, validated measure of cutaneous lupus disease activity and damage, widely used in clinical trials. CLASI consists of CLASI - activity (A) and - damage (D) measurements. CLASI-A scores range from 0 to 70, with higher scores indicating more severe disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to 12 weeks plus 30 days | — |
| Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs) | First dose date up to 12 weeks plus 30 days | — |
| Percentage of Participants Experiencing Laboratory Abnormalities | First dose date up to 12 weeks plus 30 days | — |
| Plasma Concentration of Edecesertib | Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day) | — |
| Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12 | Week 12 | The CLA-IGA is a measure of cutaneous lupus erythematosus (CLE) activity and will be recorded on a scale of 0 to 4, with 0 indicating "clear" and 4 indicating "severe". |
Countries
Germany, Spain, United States
Contacts
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed