Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Purpose
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.
Condition
- Cutaneous Lupus Erythematosus (CLE)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Edecesertib |
Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks. |
|
|
Placebo Comparator Edecesertib Placebo |
Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Gilead Sciences
Study Contact
Gilead Clinical Study Information Center1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com