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Efficacy of Delgocitinib for Dermatomyositis

Phase 2
Recruiting
Conditions
Dermatomyositis
M339
Registration Number
JPRN-jRCTs031230077
Lead Sponsor
Watanabe Tomoya
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
21
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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