BridgeMD
A Phase 3 Study to Investigate the Efficacy and Safety of Brepocitinib in Adults with Dermatomyositis
EU CTIS ID: 2022-500367-12-00
What this study is testing
To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on Total Improvement Score (TIS) after 52 weeks in comparison to placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female participant who 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 the 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies.
- Active muscle and skin disease at screening and baseline
- Current therapy or past therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
- Participants with weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2
You likely can't join if
- 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 Secondary Sjögren's syndrome)
- Participants at a risk of thrombosis and cardiovascular disease
- Participants with a high risk for herpes zoster reactivation
See the full eligibility criteria
- Male or female participant who 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 the 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies.
- Active muscle and skin disease at screening and baseline
- Current therapy or past therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
- Participants with weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2
- 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 Secondary 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
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Canada
- Taiwan
- United States
- Chile
- Turkey
- United Kingdom
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Canada; Taiwan; United States; Chile; Turkey and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.