Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) (LYNX)
Primary Purpose
Cutaneous Lupus Erythematosus
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Edecesertib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Lupus Erythematosus
Eligibility Criteria
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.
Sites / Locations
- Wallace Rheumatic Studies Center, LLC
- Clinical Research of West Florida, Inc.
- Dawes Fretzin Clincial Research Group, LLC
- DJL Clinical Research, PLLC
- Metroplex Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Edecesertib
Placebo
Arm Description
Participants will receive edecesertib orally once daily for 4 weeks
Participants will receive placebo orally once daily for 4 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants Experiencing Adverse Events
Percentage of Participants Experiencing Laboratory Abnormalities
Secondary Outcome Measures
Pharmacokinetic (PK) Parameter AUCtau of Edecesertib
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Pharmacokinetic (PK) Parameter: Cmax of Edecesertib
Cmax is defined as the maximum observed concentration of drug.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04809623
Brief Title
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Acronym
LYNX
Official Title
A Randomized, Blinded, Placebo-Controlled, Phase 1b Study of GS-5718 in Subjects With Cutaneous Lupus Erythematosus (CLE)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to terminate study.
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
October 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Edecesertib
Arm Type
Experimental
Arm Description
Participants will receive edecesertib orally once daily for 4 weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive placebo orally once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Edecesertib
Other Intervention Name(s)
GS-5718
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match edecesertib tablets administered orally
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Adverse Events
Time Frame
First dose date up to 4 weeks plus 28 days
Title
Percentage of Participants Experiencing Laboratory Abnormalities
Time Frame
First dose date up to 4 weeks plus 28 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter AUCtau of Edecesertib
Description
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Time Frame
Predose and up to 6 hours postdose at Week 4
Title
Pharmacokinetic (PK) Parameter: Cmax of Edecesertib
Description
Cmax is defined as the maximum observed concentration of drug.
Time Frame
Predose and up to 6 hours postdose at Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Wallace Rheumatic Studies Center, LLC
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Dawes Fretzin Clincial Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-497-5888
Description
Gilead Clinical Trials Website
Learn more about this trial
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
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