Study 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.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 52 weeks
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
3 Treatment Groups
Brepocitinib Dose Level 2 PO QD
1 of 3
Brepocitinib Dose Level 1 PO QD
1 of 3
Placebo PO QD
1 of 3
Experimental Treatment
Non-Treatment Group
225 Total Participants · 3 Treatment Groups
Primary Treatment: Brepocitinib · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 75 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor