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Brepocitinib for Dermatomyositis (VALOR Trial)
VALOR Trial Summary
This trial is testing a new drug to treat dermatomyositis. The goal is to see if it is better than placebo at reducing symptoms.
VALOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVALOR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VALOR Trial Design
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Who is running the clinical trial?
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- I am at risk for blood clots and heart disease.I have ongoing muscle and skin conditions.I currently have cancer.I have a disorder that affects my lymph cells.I am currently on or have been treated with steroids, hydroxychloroquine, or one non-steroid immunosuppressant.My weight is between 40kg and 130kg, and my BMI is less than 40.I haven't had cancer in the last 5 years, except for specific non-aggressive types.I have dermatomyositis with permanent muscle damage.I have been diagnosed with dermatomyositis.I am between 18 and 75 years old.My dermatomyositis has severely affected my organs.I have myositis with another connective tissue disease, but not Sjögren's syndrome.I have dermatomyositis related to my cancer.I am at high risk for shingles reactivation.I currently have or recently had an infection.
- Group 1: Brepocitinib Dose Level 2 PO QD
- Group 2: Brepocitinib Dose Level 1 PO QD
- Group 3: Placebo PO QD
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Does this research project only consider elderly patients?
"The age limit for this clinical trial is set at 74 years old. All participants must also be of legal age, which is 18 years old in most jurisdictions."
How many individuals are taking part in this clinical trial?
"In order for this clinical trial to move forward, we need 225 willing and eligible individuals. The locations where patients can participate in the study include University of Florida Health - Springhill in Gainesville, Florida and University of California - Irvine in Dallas, California."
Are there any patients needed for this clinical research at the moment?
"That is correct. As of today, the clinical trial indicated on clinicaltrials.gov is still recruiting patients. The study was originally posted on October 31st, 2020 and was last updated November 4th, 2020. Currently, the goal is to enroll 225 patients from 20 different sites."
To whom does this study open enrollment?
"This study is looking for adult patients (18-74 years old) that have been diagnosed with dermatomyositis according to the 2017 EULAR/ACR Classification Criteria. The 225 participants must also exhibit active muscle and skin disease, have prior or current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant, weigh more than 40 kg but less than 130 kg, and have a body mass index (BMI) that is below 40 kg/m2."
At how many facilities is this research being conducted?
"20 different medical centres are currently recruiting patients for this clinical trial. If you live near any of the following locations - Gainesville, Dallas and Orlando - to name a few, please consider enrolling as it will minimize travel requirements."
Could you elaborate on the side effects of Brepocitinib?
"Brepocitinib's safety is rated highly by our team because it has received a score of 3. This number reflects that the drug is currently in Phase 3 testing, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety."
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