Baricitinib for Cutaneous Dermatomyositis

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05361109
Phase
PHASE2
Status
Withdrawn

Conditions

  • Dermatomyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    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.

Study Details

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

Key Dates

Start date
Jun 1, 2022
Status verified
Aug 2023
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Barcitinib
    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.

Primary Outcome Measure

Cutaneous Disease Activity Severity Index (CDASI) activity score [ Time Frame: 24 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Medical CenterSeattleWashington98195-

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