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Protein Kinase Inhibitor
Edecesertib for Cutaneous Lupus Erythematosus
Phase 2
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening
Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postdose at week 2, predose at week 4 and 12, and week 8 (anytime of the day)
Awards & highlights
Study Summary
This trial is testing a drug to treat Cutaneous Lupus Erythematosus (CLE) to learn how effective it is and its side effects.
Who is the study for?
This trial is for individuals with Cutaneous Lupus Erythematosus (CLE) who have at least one lupus skin lesion and meet specific criteria for systemic lupus. They must have an active form of CLE, a certain severity score, and not respond well to standard treatments. People with only certain types of CLE or highly active SLE, other interfering skin conditions, significant infections or liver/cardiovascular disease cannot join.Check my eligibility
What is being tested?
The study tests the effectiveness of Edecesertib in treating CLE. Participants will either receive Edecesertib or a placebo without knowing which one they get. The study also looks into how the body processes the drug and its effects on CLE symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to Edecesertib as compared to the placebo group. This includes tracking how their bodies react to and process the medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lupus affects my skin severely and is active, with a moderate to high disease activity score.
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I have a lupus skin lesion suitable for biopsy and agree to two biopsies.
Select...
I have been diagnosed with systemic or cutaneous lupus.
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I have active cutaneous lupus affecting two different body areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postdose at week 2, predose at week 4 and 12, and week 8 (anytime of the day)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postdose at week 2, predose at week 4 and 12, and week 8 (anytime of the day)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
Secondary outcome measures
Percentage of Participants Experiencing Laboratory Abnormalities
Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EdecesertibExperimental Treatment1 Intervention
Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.
Group II: Edecesertib PlaceboPlacebo Group1 Intervention
Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.
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Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,229 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,660 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My lupus affects my skin severely and is active, with a moderate to high disease activity score.I have skin conditions that could affect lupus skin lesion assessment.I've had a bad reaction or no improvement from standard eczema treatments.I have a lupus skin lesion suitable for biopsy and agree to two biopsies.I have been diagnosed with systemic or cutaneous lupus.My lupus affects only one specific area of my body.I have an active form of lupus affecting my kidneys, brain, or blood vessels.I have active cutaneous lupus affecting two different body areas.I don't have significant infections, liver disease, or heart problems.
Research Study Groups:
This trial has the following groups:- Group 1: Edecesertib
- Group 2: Edecesertib Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any criteria that disqualify me from participating in this trial?
"Participation in this medical research project is open to individuals with cutaneous lupus erythematosus between 18 and 75 years of age, for a total recruitment size of 33 people."
Answered by AI
Is the enrollment of participants aged 75 or older permissible for this experiment?
"This clinical trial has an age limit of 18 to 75. There are 20 studies that can be enrolled in by younger patients and 117 for elderly participants."
Answered by AI
Has Edecesertib been approved by the FDA for medical use?
"As there is evidence of safety but no data concerning efficacy, our team at Power has given Edecesertib a score of 2."
Answered by AI
Are there still vacancies for prospective participants in this research endeavor?
"As demonstrated on the clinicaltrials.gov website, this study is still recruiting participants. The trial was first made available to public view on April 17th 2023 and has been updated most recently four days later."
Answered by AI
What is the enrollment number for this research study?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, first posted on April 17th 2023 and most recently updated on the 21st of April 2023, is actively searching for 33 participants across 3 sites."
Answered by AI
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