NCT05488327

Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositis

Safety and Efficacy of Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Jiangxi Provincial People's Hopital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the efficacy and safety of lenalidomide in the treatment of patients with active cutaneous DM.

Detailed description

Dermatomyositis (DM) are systemic immune-mediated inflammatory diseases which commonly affected the skin and musculoskeletal system. The cutaneous manifestations of DM are the most important aspect of this disease. Treatment of these cutaneous manifestations is challenging and currently no universally effective drugs exists. Lenalidomide, a second-generation derivative of thalidomide, has a role as an angiogenesis inhibitor, an antineoplastic agent and an immunomodulator. Reports on refractory cutaneous manifestations of systemic lupus erythematosus have been mostly performed. The clinical trials of lenalidomide for cutaneous DM are lacking. This is a single-centre, prospective, open-label, single-arm study with Lenalidomide 5mg/day added to the background treatment of GCs and immunosuppressants in DM to evaluate the efficacy and safety of lenalidomide in the treatment of cutaneous DM.

Conditions

• Dermatomyositis

Interventions

Type	Name	Description
DRUG	Lenalidomide	All subjects will be treated with lenalidomide 5mg/day with a regular follow-up of 24 weeks.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2023-09-01
• First posted: 2022-08-04
• Last updated: 2022-08-04

Locations

1 site across 1 country: China