A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis

Priovant Therapeutics

Status and phase

Completed

Phase 2

Conditions

Dermatomyositis

Dermatomyositis, Adult Type

Treatments

Drug: Brepocitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06433999

PVT-2201-202

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
Active cutaneous manifestations of dermatomyositis
Adult subjects (18-75 years old)
Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2.

Exclusion criteria

Dermatomyositis with end-stage organ involvement
Dermatomyositis with irreversible muscle involvement

History of:

Any lymphoproliferative disorder
Active malignancy;
History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associated dermatomyositis
Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
Participants at a risk of thrombosis or cardiovascular disease
Participants with a high risk for herpes zoster reactivation
Participants with active or recent infections