A Phase 3 Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

Overview

About this study

The purpose of this study is to determine the effetiveness and safety of brepocitinib (a tyrosine kinase [TYK] 2/Janus kinase [JAK] 1 inhibitor) in patients with dermatomyositis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/1/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Floranne Ernste, M.D.

Open for enrollment

Contact information:

Shirleyannofos Osei Onomah M.P.H.

(507) 266-4175

Osei-Onomah.Shirleyannofos@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Sluzevich, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available