Brepocitinib for Dermatomyositis

Recruiting in Palo Alto (17 mi)

Overseen byMangold, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Priovant Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 75 years old.

My weight is between 40kg and 130kg, and my BMI is less than 40.

I have visible skin symptoms of dermatomyositis.

+1 more

Exclusion Criteria

I have a history of cancer.

I am at risk for blood clots or heart disease.

My dermatomyositis has caused severe damage to my organs.

+6 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: BrepocitinibExperimental Treatment1 Intervention