NCT04062019

Low-dose Interleukin-2 Treatment on Idiopathic Inflammatory Myopathy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) on idiopathic inflammatory myopathy (IIM).

Detailed description

The investigators designed a single center, open-label, prospective study. Adults with active IIM will be enrolled. IIM is defined as Dermatomyositis (DM) or Polymyositis (PM), meeting the Bohan \& Peter (1975) diagnostic criteria for definite or probable DM or PM. One million units of Recombinant Human Interleukin-2 (rhIL-2) was administered subcutaneously every other day for 3 months. All patients were followed up for 3 months after withdraw of IL-2.

Conditions

• Inflammatory Myopathy

Interventions

Type	Name	Description
DRUG	Interleukin-2	low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU/m2 once every other day, for 3 months.

Timeline

• Start date: 2019-08-30
• Primary completion: 2021-03-31
• Completion: 2021-06-30
• First posted: 2019-08-20
• Last updated: 2019-08-28