Clinical Characteristics and Mechanism Research of Deucravacitinib in the Idiopathic Inflammatory Myopathies

NCT07564271 — Withdrawn, Peking University People's Hospital

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Real-world Experience With Deucravacitinib for the Treatment of Idiopathic Inflammatory Myopathies -- a Prospective Observational Study

Registry	NCT07564271
Status	Withdrawn - Plan change: Plan to add a center
Study type	Observational
Sponsor	Peking University People's Hospital (Other)
Conditions	Idiopathic Inflammatory Myopathies (IIMs)
Interventions	Deucravacitinib 6mg po qd (Drug)
Dates	start 2025-10-05, primary completion 2026-07-01 (estimated), completion 2026-10-01 (estimated), first posted 2026-05-04, last updated 2026-07-09
Locations	1 site in China

-Summary

This study aims to explore the clinical characteristics and mechanism of Deucravacitinib in the treatment of idiopathic inflammatory myopathies.Detailed Description: The investigators designed a single center, open-label, prospective study. Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan \& Peter Dermatomyositis/Polymyositis(DM/PM) or Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. Deucravacitinib 6 mg once a day was administered for 6 months to explore its efficacy and safety, which could help to evaluate Deucravacitinib clinical characteristics and mechanism. Patients would be evaluated the improvement of clinical and laboratory indexes. Changes of symptoms, immune cell subsets and cytokines were monitored. Symptoms were evaluated by Visual Analogue Scale (VAS) of patient global and physician global, manual muscle testing(MMT-8), the Health Assessment Questionnaire(HAQ), Creatine kinase, Myositis Disease Activity Assessment Tool(MDAAT).

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+Arms and interventions

Deucravacitinib 6mg po qd (Drug): Deucravacitinib 6mg once a day for 6 months.

+Outcome measures

Primary outcomes

IMACS-defined improvement [week 24]: The International Myositis Assessment and Clinical Studies (IMACS) definition of improvement (DOI) criteria require improvement of ≥20% in at least three of the six Core Symptom Metrics (CSMs), with no more than two CSMs showing a worsening of ≥25% (excluding MMT-8);

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* Adults between 18 years and 75 years of age.

  * Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan \& Peter DM/PM or American College of Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria.
  * Active disease: MDAAT skin VAS ≥ 3 cm, with at least 3 core indicators abnormal;
  * Inadequate response to or intolerance of conventional treatments (such as glucocorticoids, immunosuppressants).

Exclusion Criteria:

* Any subject meeting either of the following criteria should be excluded:

  * Combined with other systemic autoimmune diseases;
  * Severe hepatic and renal dysfunction;
  * Active infections (such as tuberculosis, hepatitis B, HIV);
  * Pregnant or lactating women;
  * Previous use of JAK inhibitors.

+Locations (1)

Facility	City	Country	Status
Department of Rheumatology and Immunology, Peking University People's Hospital	Beijing, Beijing Municipality	China

+Publications

Rayavarapu S, Coley W, Kinder TB, Nagaraju K. Idiopathic inflammatory myopathies: pathogenic mechanisms of muscle weakness. Skelet Muscle. 2013 Jun 7;3(1):13. doi: 10.1186/2044-5040-3-13. PMID 23758833
Aggarwal R, Rider LG, Ruperto N, Bayat N, Erman B, Feldman BM, Oddis CV, Amato AA, Chinoy H, Cooper RG, Dastmalchi M, Fiorentino D, Isenberg D, Katz JD, Mammen A, de Visser M, Ytterberg SR, Lundberg IE, Chung L, Danko K, Garcia-De la Torre I, Song YW, Villa L, Rinaldi M, Rockette H, Lachenbruch PA, Miller FW, Vencovsky J; International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation. 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative. Ann Rheum Dis. 2017 May;76(5):792-801. doi: 10.1136/annrheumdis-2017-211400. PMID 28385805
Morand E, Merola JF, Tanaka Y, Gladman D, Fleischmann R. TYK2: an emerging therapeutic target in rheumatic disease. Nat Rev Rheumatol. 2024 Apr;20(4):232-240. doi: 10.1038/s41584-024-01093-w. Epub 2024 Mar 11. PMID 38467779
McNamara ME, Tjahjono L. Successful treatment of recalcitrant amyopathic dermatomyositis with deucravacitinib in addition to intravenous immunoglobulin. JAAD Case Rep. 2025 Mar 29;62:6-8. doi: 10.1016/j.jdcr.2025.01.047. eCollection 2025 Aug. No abstract available. PMID 40642501

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