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 (18-74 years old).

- Active muscle and skin disease at screening and baseline.

- 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/m^2.

Exclusion Criteria:

- Dermatomyositis with end-stage organ involvement.

- Dermatomyositis with irreversible muscle involvement.

- History of:

- Any lymphoproliferative disorder;

- Active malignancy;

- 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 7/29/22. 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.

Closed for enrollment

Contact information:

Emma Torrens-Burton

5072932110

torrens-burton.emma@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Closed for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Sluzevich, M.D.

Closed for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available