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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04809623
Other study ID # GS-US-497-5888
Secondary ID 2021-000204-38
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 1, 2021
Est. completion date October 18, 2022

Study information

Verified date October 2023
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date October 18, 2022
Est. primary completion date October 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Drug:
Edecesertib
Tablets administered orally
Placebo
Placebo to match edecesertib tablets administered orally
Standard of Care
Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)

Locations

Country Name City State
United States Wallace Rheumatic Studies Center, LLC Beverly Hills California
United States DJL Clinical Research, PLLC Charlotte North Carolina
United States Clinical Research of West Florida, Inc. Clearwater Florida
United States Metroplex Clinical Research Center Dallas Texas
United States Dawes Fretzin Clincial Research Group, LLC Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Experienced Treatment-emergent Adverse Events Treatment-emergent Adverse Events (TEAEs) were defined as AEs with onset dates on or after the study treatment start date and no later than 28 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatments. First dose date up to 4 weeks plus 28 days
Primary Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 28 days after last study drug administration. First dose date up to 4 weeks plus 28 days
Secondary 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
Secondary 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
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