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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
Summary
This trial is testing a new medication called edecesertib to see if it is safe for people with skin-related lupus, with or without systemic lupus.
Eligible Conditions
- Cutaneous Lupus Erythematosus
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Who Experienced Treatment-emergent Adverse Events
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Secondary study objectives
Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib
Pharmacokinetic (PK) Parameter: Cmax of Edecesertib
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
1,130 Previous Clinical Trials
867,124 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
358 Previous Clinical Trials
192,113 Total Patients Enrolled
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