NCT05361109

Baricitinib for Cutaneous Dermatomyositis

An Open-Label Pilot Study to Evaluate the Efficacy and Safety of Baricitinib in Subjects With Cutaneous Dermatomyositis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, single-center study in patients with active cutaneous DM who have had an inadequate response. An inadequate response is defined as no improvement with standard of care treatment based on the investigator's opinion. All subjects will initially receive baricitinib 2mg daily for 8 weeks. If no unexpected serious adverse events related to baricitinib have occurred during the first 8 weeks of treatment in the opinion of the investigator, the dose will be increased to 4 mg daily for 16 weeks. Visits are scheduled at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks. Evaluation of primary endpoint occurs at week 24. All subjects receive a phone call from study

Conditions

• Dermatomyositis

Interventions

Type	Name	Description
DRUG	Baricitinib	The investigational medicinal product (IP) for this study is baricitinib 2mg. The dose will be administered as one 2mg tablet by mouth once daily for the first 8 weeks of study. If no unexpected serious adverse events related to baricitinib in the opinion of the investigator occur during the first 8 weeks of treatment, the dose will be increased to two 2mg tablets (4mg daily) for the remaining 16 weeks of study. All study participants will take baricitinib in combination with standard of care background therapy.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-05-04
• Last updated: 2023-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study