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

Phase 1

Terminated

• Conditions: Cutaneous Lupus Erythematosus
• Interventions: Drug: Edecesertib; Drug: Placebo; Drug: Standard of Care

• Registration Number: NCT04809623
• Lead Sponsor: Gilead Sciences

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Study Start: 2021-09-01
• Primary Completion: 2022-10-18
• Study Completion: 2022-10-18
• Status Verified: 2023-10
• Results First Submitted: 2023-10-06
• Results First Submitted QC: 2023-10-06
• Last Update Submitted: 2023-10-06
• Results First Posted: 2024-04-05
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edecesertib	Edecesertib	Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.
Edecesertib	Standard of Care	Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.
Placebo	Placebo	Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.
Placebo	Standard of Care	Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities	First dose date up to 4 weeks plus 28 days	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.
Percentage of Participants Who Experienced Treatment-emergent Adverse Events	First dose date up to 4 weeks plus 28 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

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

Dawes Fretzin Clincial Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States