JPRN-jRCTs031230077
Recruiting
Phase 2
Single-arm phaseII trial to Efficacy and Safety of Delgocitinib Ointment for Skin Symptoms of Dermatomyositis
Watanabe Tomoya0 sites21 target enrollmentMay 16, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Dermatomyositis
- Sponsor
- Watanabe Tomoya
- Enrollment
- 21
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Men and women 18 years of age or older at the time of enrollment
- •(2\) Patients diagnosed with dermatomyositis
- •(3\) Patients with stable interstitial pneumonia or myositis after systemic therapy with oral steroids or immunosuppressive drugs
- •(4\) Patients with residual skin rash after systemic therapy with oral steroids or immunosuppressive agents, patients with flare\-ups of skin rash after tapering off of oral steroids or immunosuppressive agents, or patients with skin rash alone without myositis or interstitial pneumonia and not eligible for systemic therapy
- •(5\) Patients in (4\) who have a skin rash refractory to treatment despite standard therapy\*.
- •(6\) Patients who are able to walk independently and answer questionnaires
- •(7\) Patients who give written consent to participate in this study.
Exclusion Criteria
- •(1\) Patients with a history of hypersensitivity to delgocitinib
- •(2\) Women who are pregnant, lactating, may be pregnant, or wish to become pregnant during the treatment period
- •(3\) Patients with severe skin infections
- •(4\) Patients with dermatomyositis who have anti\-ARS antibody
- •(5\) Patients who are judged by doctor to be inappropriate as subjects
Outcomes
Primary Outcomes
Not specified
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