Brepocitinib for Dermatomyositis

(VALOR Trial)

Recruiting in Palo Alto (17 mi)

+116 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Priovant Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests brepocitinib, a drug that blocks inflammation-causing proteins, in adults with dermatomyositis. The goal is to see if it improves symptoms like muscle weakness and skin rashes by reducing inflammation. Another similar drug has shown positive results in treating difficult cases of dermatomyositis.

Eligibility Criteria

Adults aged 18-75 with dermatomyositis, weighing between 40-130 kg and a BMI under 40. Participants must have active muscle and skin disease, may be on or have had corticosteroids or immunosuppressants, and meet specific diagnostic criteria. Excluded are those with recent cancers (with some exceptions), high thrombosis risk, severe infections, irreversible muscle damage from the disease, end-stage organ involvement, certain other diseases or conditions.

Inclusion Criteria

I have ongoing muscle and skin conditions.

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.

Exclusion Criteria

I am at risk for blood clots and heart disease.

I currently have cancer.

I have a disorder that affects my lymph cells.

Participant Groups

The trial is testing Brepocitinib's effectiveness compared to a placebo in adults with dermatomyositis over a year. It measures improvement using the Total Improvement Score. After this phase, participants can join an open-label extension for another year where everyone receives Brepocitinib.

Group I: Brepocitinib Dose Level 2 PO QD Experimental Treatment 1 Intervention

Group II: Brepocitinib Dose Level 1 PO QD Experimental Treatment 1 Intervention

Group III: Placebo PO QD Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Florida Health - Springhill Gainesville, FL

University of California - Irvine Irvine, CA

Arizona Neuromuscular Research Center Phoenix, AZ

Tulane University School of Medicine New Orleans, LA

More Trial Locations

Who Is Running the Clinical Trial?

Priovant Therapeutics, Inc. Lead Sponsor

References