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Daxdilimab for Alopecia Areata
Study Summary
This trial is testing a new drug to treat people with moderate to severe Alopecia Areata who have lost 50-95% of their hair.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You don't have any current or recent significant regrowth of the condition being studied.You have tested positive for hepatitis B or C.You have ongoing skin conditions or signs of inflammation on your skin.You have a serious medical condition or abnormal test results.You spend a lot of time in the sun, use tanning booths often, or don't want to limit your time in the sun.You have a history of immune system problems, HIV infection, or had your spleen removed.You have already been treated with certain biologic therapies, or did not respond well to oral Janus Kinase (JAK) inhibitors.You have a different type of hair loss or have had hair transplants or micropigmentation.You have been experiencing hair loss for more than 3 months but less than 7 years, and the doctor thinks your hair can grow back.You have taken certain drugs within a certain period of time before the trial.You have between 50% and 95% hair loss on your scalp, as determined by a scoring system.You had cancer or a certain type of disease in your blood within the last 5 years, unless special circumstances apply.You are willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.You have tuberculosis that is not being treated.You have a severe infection from the herpes virus family, or you have unresolved herpes zoster, CMV, or Epstein-Barr virus infection.You have a serious infection or recently tested positive for COVID-19.You have had UV-B phototherapy, PUVA treatment, or excimer laser treatment recently.You are a man or woman between 18 and 65 years old.You have been diagnosed with moderate-to-severe aplastic anemia based on specific criteria.You are currently using or have recently used non-biological drugs or devices.
- Group 1: Daxdilimab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
In how many different geographical areas is this trial being run today?
"There are 11 total trial sites for this clinical study, including Burke Pharmaceutical Research in Hot Springs, Arkansas, Dermatology Specialists of Spokane in Spokane, Washington, and Investigate MD in Scottsdale, Arizona."
Who meets the requirements to enroll in this clinical trial?
"This medical trial is looking for 30 patients that currently suffer from alopecia areata and meet the following requirements: Be between 18-65 years old, give informed consent, keep the same hair style/color for the duration of the trial, have 50-95% total scalp hair loss, current episode of hair loss >3 months but <7 years, no evidence of active regrowth present at baseline, willing to comply with prescribed treatment protocol and evaluations."
Does Daxdilimab have a high potential for patient harm?
"Daxdilimab is a medication that is still in the early stages of clinical trials. There is some supporting evidence for its safety, but none yet for its efficacy, so it received a score of 2."
Are investigators still signing up participants for this experiment?
"The most recent update on clinicaltrials.gov shows that this trial is still looking for patients. This information was updated on May 5th, 2022, and the trial was originally posted on April 27th, 2022."
Is this research study only enrolling volunteers who are 20 years or older?
"The age limit for applicants of this clinical trial is 65. If an applicant is under 18, there are 10 other trials that they may be eligible for. For patients above the age of 65, 67 different trials exist."
How many people are being given this treatment?
"Horizon Therapeutics Ireland DAC, the sponsor of this clinical trial, needs to recruit 30 eligible patients from locations such as Burke Pharmaceutical Research in Hot Springs, Arkansas and Dermatology Specialists of Spokane in Spokane, Washington."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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