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Daxdilimab for Discoid Lupus (RECAST DLE Trial)
RECAST DLE Trial Summary
This trial will test a drug to treat Discoid Lupus Erythematosus, a skin disorder, to see if it is safe and effective.
RECAST DLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRECAST DLE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RECAST DLE Trial Design
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Who is running the clinical trial?
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- My weight is over 352 pounds.I have had allergic reactions to specific medications or treatments before.I have had no cancer in the past 5 years, except for treated skin cancer or cervical cancer.I tested negative for active hepatitis C.I do not have active TB or untreated latent TB.I have not been hospitalized or needed IV antibiotics for an infection in the last 2 years.I have been diagnosed with systemic lupus erythematosus according to the 2020 criteria.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with a systemic connective tissue disease.I have had my spleen removed.You have a specific score related to discoid lesions that is higher than 8.I have active discoid lupus confirmed by a photo review.I do not have a skin condition that could affect the study's skin assessments.I do not have any current infections or serious illnesses.I am not pregnant or breastfeeding and follow the required contraceptive measures.I have had herpes, CMV, or Epstein-Barr virus infections fully resolved more than 12 weeks ago.I am a male and agree to follow the study's contraceptive requirements.My DLE has not improved despite treatment.I have had serious heart problems in the last 6 months.I have been diagnosed with discoid lupus for over 6 months.
- Group 1: Placebo/Daxdilimab Arm 1
- Group 2: Daxdilimab Arm 2
- Group 3: Daxdilimab Arm 3
- 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
To whom does this study cater?
"This lupus erythematosus study, which is looking for around 99 participants, requires that patients have discoid and be between 18-75 years old."
How many people fit the eligibility criteria for this experiment?
"In order to obtain accurate results, 99 patients that fall under the specified inclusion criteria must participate in this trial. This can be done by visiting one of the many locations such as Alberta DermaSurgery Centre or The Center for Dermatology Clinical Research."
Are new participants being signed up for this research project?
"The trial is still recruiting patients, according to the clinicaltrials.gov website. This research was first posted on October 12th, 2022 and was last edited 19 days ago."
Does Daxdilimab Arm 3 have any harmful side effects for people?
"Although there is no data yet supporting the efficacy of Daxdilimab Arm 3, it has been given a safety rating of 2 because some clinical data exists to support its safety."
Are minors welcome in this research project?
"Enrolment into this study is available for patients aged 18 to 75. There are 17 other trials targeting those under 18 and 111 that focus on individuals over 65 years old."
How many places are managing this trial?
"Patients are being accepted at this clinical trial's Alberta DermaSurgery Centre in Edmonton, The Center for Dermatology Clinical Research in Fremont, and Bayview North Dermatology Clinic in North York as well as 22 other locations."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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