Efficacy of Delgocitinib for Dermatomyositis

JRCT ID: jRCTs031230077

Registered date:16/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dermatomyositis
• Date of first enrollment: 08/02/2024
• Target sample size: 21
• Study type: Interventional
• Intervention(s): Delgocitinib ointment application

Outcome(s)

• Primary Outcome: Improvement rate of skin rash after 8 weeks of topical application

Secondary Outcome

Safety and side effects during the period of topical application.
Physician's skin activity assessment VAS and patient's skin activity assessment VAS at 8 weeks after the start of topical application.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Watanabe Tomoya
• Secondary Sponsor: Yamaguchi Yukie