A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

About

Brief Summary

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

75 Years

Inclusion Criteria:

A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
Adult subjects (18-75 years old)
Active muscle and skin disease at screening and baseline
Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
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 screening (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 and cardiovascular disease
Participants with a high risk for herpes zoster reactivation
Participants with active or recent infections

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