Brepocitinib for Dermatomyositis

Overseen By Matt Cascino, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Priovant Therapeutics, Inc.

Disqualifiers: Lymphoproliferative disorder, active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

5 Participants Needed

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.

Research Team

Mangold, MD

Principal Investigator

Mayo Clinic

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

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

I have visible skin symptoms of dermatomyositis.

I have been diagnosed with dermatomyositis.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 8 weeks

Treatment

Participants receive brepocitinib 30 mg orally once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brepocitinib

Trial Overview 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.

Participant Groups

Group I: Brepocitinib Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Priovant Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

570+