Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06433999 - A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis Phase 2
Completed NCT03529955 - Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis Phase 2
Recruiting NCT05375435 - Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis Phase 4
Recruiting NCT04966884 - The Efficacy and Safety of JAK Inhibitor in the Treatment of Anti-MDA5 Antibody-positive Dermatomyositis Patients Phase 4