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Kinase Inhibitor

Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) (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 weeks
Treatment ~ Varies
Follow Up ~first dose date up to 4 weeks plus 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to 4 weeks plus 28 days for reporting.

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

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,135 Previous Clinical Trials
868,033 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
360 Previous Clinical Trials
192,484 Total Patients Enrolled
~1 spots leftby Dec 2025
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