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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cutaneous Lupus Erythematosus

Intervention / Treatment
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* Drug: Edecesertib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Either fulfill Image result for eular medical abbreviation The European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for SLE or have biopsy-proven 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 Cutaneous LE 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 Key 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edecesertib<br>Participants will receive edecesertib orally once daily for 4 weeks | Drug: Edecesertib<br>* Tablets administered orally<br>* Other names: GS-5718;|
| Experimental: Placebo<br>Participants will receive placebo orally once daily for 4 weeks | Drug: Placebo<br>* Placebo to match edecesertib tablets administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Adverse Events |  | First dose date up to 4 weeks plus 28 days | 
| Percentage of Participants Experiencing Laboratory Abnormalities |  | First dose date up to 4 weeks plus 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) Parameter AUCtau of Edecesertib | AUCtau is defined as the area under the concentration versus time curve over the dosing interval. | Predose and up to 6 hours postdose at Week 4 | 
| Pharmacokinetic (PK) Parameter: Cmax of Edecesertib | Cmax is defined as the maximum observed concentration of drug. | Predose and up to 6 hours postdose at Week 4 |