Clinical trial NCT04809623: Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Official title: A Randomized, Blinded, Placebo-Controlled, Phase 1b Study of GS-5718 in Subjects With Cutaneous Lupus Erythematosus (CLE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cutaneous Lupus Erythematosus
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 3
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 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).


Eligibility criteria: Key Inclusion Criteria:

* Either fulfill the European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) or have biopsy-proven cutaneous lupus erythematosus (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.
* CLE 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.

Primary outcomes:
measure: Percentage of Participants Who Experienced Treatment-emergent Adverse Events
timeFrame: First dose date up to 4 weeks plus 28 days
measure: Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
timeFrame: First dose date up to 4 weeks plus 28 days
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib
timeFrame: Predose and up to 6 hours postdose at Week 4
measure: Pharmacokinetic (PK) Parameter: Cmax of Edecesertib
timeFrame: Predose and up to 6 hours postdose at Week 4
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Studies Center, LLC
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clincial Research Group, LLC
state: Indiana
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: