MedTrace Logo

Baricitinib for Cutaneous Dermatomyositis

NCT05361109 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Kwanghoon Han, MD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361109 on ClinicalTrials.gov