drugset / Trial / NCT05361109

Baricitinib for Cutaneous Dermatomyositis

NCT05361109

Phase 2 Withdrawn University of Washington
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2022-06-01
Primary completion
2023-03-31
Completion
2023-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Baricitinib Small molecule 4 mg Oral

Indications