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Janus Kinase Inhibitor

Brepocitinib for Dermatomyositis

Phase 2
Waitlist Available
Led By Mangold, MD
Research Sponsored by Priovant Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult subjects (18-75 years old)
Active cutaneous manifestations of dermatomyositis
Must not have
History of active malignancy
Dermatomyositis with irreversible muscle involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of a medication called brepocitinib on individuals with a skin condition called dermatomyositis. Participants will take brepocitinib for 12 weeks after

Who is the study for?
This trial is for adults aged 18-75 with dermatomyositis, specifically those who have skin symptoms but little to no muscle issues. Participants should weigh between 40 and 130 kg with a BMI under 40 kg/m2.
What is being tested?
The study tests Brepocitinib's effectiveness and safety in treating skin-related symptoms of dermatomyositis over a period of 12 weeks. Patients will take the medication daily by mouth.
What are the potential side effects?
While specific side effects are not listed here, brepocitinib may cause typical drug reactions such as nausea, headaches, or more serious ones depending on how it affects the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have visible skin symptoms of dermatomyositis.
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My weight is between 40kg and 130kg, and my BMI is less than 40.
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I have been diagnosed with dermatomyositis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of cancer.
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I have dermatomyositis with permanent muscle damage.
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I have had a condition where my lymphocytes grow abnormally.
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My dermatomyositis has caused severe damage to my organs.
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I currently have or recently had an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BrepocitinibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brepocitinib
2022
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Priovant Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
567 Total Patients Enrolled
1 Trials studying Dermatomyositis
241 Patients Enrolled for Dermatomyositis
Mangold, MDPrincipal InvestigatorMayo Clinic
~1 spots leftby Feb 2025
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