IRB Study Number 22-1153
Status Recruiting
Phase Phase 3
Location A Building - Crile Building
Institute Dermatology and Plastic Surgery Institute
Description
We invite you to take part in a research study because you have been diagnosed with dermatomyositis. The purpose of this study is to learn more about the investigational medicine, called brepocitinib, for the treatment of dermatomyositis. The study will also look at how safe and effective brepocitinib is and will monitor the long-term safety of brepocitinib when given for a period of 104 weeks.
Inclusion Criteria
Male or female, and the participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent form (ICF).
Participants with a diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
Participants meeting both of the following disease severity criteria(at screening and
randomization):
• MMT-8 score ≥ 80 and ≤ 142 (out of 150 total possible) and
• Active cutaneous manifestation of dermatomyositis documented as CDASI Activity Score ≥ 6.
For participants with onset of dermatomyositis symptoms within 3 years of screening, have a documented computed tomography (CT) (or positron emission tomography computed tomography [PET-CT]) scan with contrast of the chest, abdomen, and pelvis, taken after the onset of symptoms and within 1 year of screening, without findings suggestive of malignancy.
Current therapy consisting of corticosteroid ≤ 20 mg/day (including a dose of 0 mg [i.e., not taking corticosteroid]) of prednisone or equivalent (see Appendix 2 for commonly-used corticosteroid equivalents). The dose must be stable for at least 4 weeks, and total duration of therapy at least 12 weeks, prior to randomization.
At most, one non-steroid immunomodulatory/immunosuppressive therapy (see Table 5 for eligible therapies and maximally allowed dose), with a stable dose for at least 12 weeks prior to randomization.
Exclusion Criteria
In the opinion of the investigator, dermatomyositis with end-stage organ involvement that will pose additional risk to the participant or confound the assessment of the participant in the study. This may include advanced symptomatic ILD (for example, abnormal forced vital capacity [FVC] and/or requiring oxygen therapy), severe dysphagia impacting compliance with oral therapies, etc.
In the opinion of the investigator, dermatomyositis with irreversible muscle involvement and/or severe atrophy that will pose any additional risk to the participant or confound the assessment of the participant in the study. This may include Muscle Damage-VAS ≥ 5 cm, documented history of severe atrophy (based on MRI), and/or wheelchair bound.
Calcinosis that is motion-limiting and would prevent accurate assessment of disease activity (e.g., unable to properly perform MMT-8).
History of any lymphoproliferative disorder (such as Epstein-Barr virus [EBV]-related lymphoproliferative disorder, lymphoma, leukemia).
Cancer-associated condition, cancer, or history meeting any of the following conditions:
• Active malignancy;
• History of cancer within 5 years prior to screening, with the exception of the following cancers with documentation of complete resection and no evidence of recurrence for ≥ 1 year: basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.
