Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositis

Dermatomyositis, Adult Type Clinical Trial

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Clinical Activity of Itolizumab in Subjects With Dermatomyositis

Status Not yet recruiting

Clinical Trial Summary

To evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of Itolizumab in subjects with Dermatomyositis.

Clinical Trial Description

The study will enroll approximately 44 subjects in two parts: Part 1 is an open label, 3+3 single dose escalation and then mutiple dose administration phase. 9~30 patients with DM are expected to be enrolled across 3 dose cohorts. Part 2 is a randomized phase and will enroll approximately 14 additional subjects, randomized in a 1:1 ratio to one of the 2 doses based on efficacy data obtained from Part 1. All participants in this study will receive Itolizumab intravenously every two weeks for a total of 7 doses. ;

Related Conditions & MeSH terms

• Dermatomyositis
• Dermatomyositis, Adult Type

• NCT number: NCT05986162
• Study type: Interventional
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: Xijuan Song
• Phone: 010-51571020
• Email: songxijuan@biotechplc.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 30, 2023
• Completion date: June 25, 2025