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New treatment option for Dermatomyositis
Official title Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
ClinicalTrials.gov ID: NCT06857240
What this study is testing
What is Ruxolitinib Topical Cream?
Ruxolitinib Topical Cream is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for dermatomyositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will assess the safety and efficacy of topical ruxolitinib for treating the refractory cutaneous manifestations in patients with dermatomyositis. The investigators' hypothesis is that topical ruxolitinib will be both safe and effective for such patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Patients 18 years and older with refractory cutaneous symptoms related to either classic dermatomyositis (CD), juvenile dermatomyositis (JD), or...
- Patients must have had a skin biopsy with histologic features consistent with dermatomyositis and current cutaneous manifestations consistent with...
- Patients will be considered to have refractory disease if cutaneous manifestations exist despite treatment with systemic corticosteroids and at least...
- Patients must have sufficiently active cutaneous involvement of dermatomyositis (BSA\>1% to \ 6, and Physician Global Assessment (PGA) activity score...
- Patients must have tried and failed at least one commonly prescribed topical medication in the past, with the last application of a topical...
You likely can't join if
- Patients with dermatomyositis who have minimal-to-no active cutaneous disease (mild involvement with \< 1% total body surface area involved and/or...
- Patients who have \> 20% total BSA involvement of cutaneous dermatomyositis.
- Patients who have used a common prescription topical medication within the previous 2 weeks.
- Patients whose cutaneous findings are not consistent with dermatomyositis and/or have previous biopsy results suggestive of an alternative diagnosis
- Patients not on stable systemic medication regimens for at least 2 months and/or who will not agree to keep the regimen stable throughout the study...
- Patients who have previously taken a systemic Janus kinase inhibitor but had a poor response, patients who are currently taking systemic Janus kinase...
See the full eligibility criteria
- Patients 18 years and older with refractory cutaneous symptoms related to either classic dermatomyositis (CD), juvenile dermatomyositis (JD), or amyopathic dermatomyositis (AD). Diagnosis will be based on either Bohan...
- Patients must have had a skin biopsy with histologic features consistent with dermatomyositis and current cutaneous manifestations consistent with dermatomyositis.
- Patients will be considered to have refractory disease if cutaneous manifestations exist despite treatment with systemic corticosteroids and at least one steroid-sparing systemic treatment commonly found to be useful in...
- Patients must have sufficiently active cutaneous involvement of dermatomyositis (BSA\>1% to \ 6, and Physician Global Assessment (PGA) activity score \>2).
- Patients must have tried and failed at least one commonly prescribed topical medication in the past, with the last application of a topical medication to active skin lesions occurring greater than 2 weeks prior to...
- Patients must have been on a stable systemic medication regimen for at least 2 months (60 days) and must agree to keep the regimen stable throughout the study period. As patients with dermatomyositis are commonly...
- Patients must be agreeable to use appropriate contraceptive measures while enrolled in the study.
- Women of childbearing potential must be willing to practice abstinence or use either an oral contraceptive medication or IUD if sexually active.
- Women of childbearing potential must be willing to have monthly urine pregnancy tests while enrolled in the study
- Men of childbearing potential must be willing to practice abstinence or use condoms if sexually active.
- Patients with dermatomyositis who have minimal-to-no active cutaneous disease (mild involvement with \< 1% total body surface area involved and/or CDASI activity score of \< 6).
- Patients who have \> 20% total BSA involvement of cutaneous dermatomyositis.
- Patients who have used a common prescription topical medication within the previous 2 weeks.
- Patients whose cutaneous findings are not consistent with dermatomyositis and/or have previous biopsy results suggestive of an alternative diagnosis
- Patients not on stable systemic medication regimens for at least 2 months and/or who will not agree to keep the regimen stable throughout the study period.
- Patients who have previously taken a systemic Janus kinase inhibitor but had a poor response, patients who are currently taking systemic Janus kinase inhibitors, or patients who have used a topical Janus kinase...
- Patients with inflammatory myositis other than dermatomyositis, such as polymyositis or inclusion body myositis.
- Patients with clear features of an overlap autoimmune myositis or with an inflammatory myositis not consistent with dermatomyositis, such as polymyositis or inclusion body myositis.
- Patients with an active malignancy other than non-melanoma skin cancer, or with malignancy-associated dermatomyositis.
- Patients younger than 18 years old
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
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, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. 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 ClinicalTrials.gov; the study team decides eligibility.