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Kinase Inhibitor
Edecesertib for Cutaneous Lupus Erythematosus (LYNX Trial)
Phase 1
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date up to 4 weeks plus 28 days
Awards & highlights
LYNX Trial Summary
This study is evaluating whether a drug called GS-5718 is safe and well tolerated in people with cutaneous lupus erythematosus.
Eligible Conditions
- Cutaneous Lupus Erythematosus
LYNX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose date up to 4 weeks plus 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose date up to 4 weeks plus 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Who Experienced Treatment-emergent Adverse Events
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Secondary outcome measures
Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib
Pharmacokinetic (PK) Parameter: Cmax of Edecesertib
LYNX Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment2 Interventions
Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.
Group II: EdecesertibExperimental Treatment2 Interventions
Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,259 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,690 Total Patients Enrolled
Frequently Asked Questions
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