NCT05986162

Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositis

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Dermatomyositis, Adult Type

Interventions

Type	Name	Description
DRUG	Itolizumab	Patients to be treated with Itolizumab.

Timeline

• Start date: 2023-12-30
• Primary completion: 2025-05-03
• Completion: 2025-06-25
• First posted: 2023-08-14
• Last updated: 2023-08-14