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NCT05361109

Baricitinib for Cutaneous Dermatomyositis

Withdrawn Phase 2 Last updated 1 September 2023
What this trial tests

Phase 2 trial testing Baricitinib in Dermatomyositis. Withdrawn.

Timeline
1 June 2022
Primary endpoint
31 March 2023
31 March 2023

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 2
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Start date1 June 2022
Primary completion31 March 2023
Estimated completion31 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, any sex, with Dermatomyositis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical pearls and promising therapies in myositis.
    Connolly CM, Paik JJ. · · 2023 · cited 8× · PMID 37158055 · DOI 10.1080/1744666x.2023.2212162
  2. Targeting intracellular pathways in idiopathic inflammatory myopathies: A narrative review.
    La Rocca G, Ferro F, Baldini C, Libra A, et al · · 2023 · cited 7× · PMID 36993798 · DOI 10.3389/fmed.2023.1158768
  3. Leveraging Genomic and Bioinformatic Analysis to Enhance Drug Repositioning for Dermatomyositis.
    Irham LM, Adikusuma W, La'ah AS, Chong R, et al · · 2023 · cited 1× · PMID 37627776 · DOI 10.3390/bioengineering10080890

Verify or expand the search:

Other trials of Baricitinib

Trials testing the same drug.

Other recruiting trials for Dermatomyositis

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05361109.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing