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

Cutaneous Lupus Erythematosus Clinical Trial

— LYNX  

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

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

External Links

•   Gilead Clinical Trials Website