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

NCT07564271 | Recruiting

• 1 other identifier: 20260303 Deucravacitinib-IIM
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Idiopathic Inflammatory Myopathies (IIMs)

Outcome Measures

Primary Outcomes (1)

• IMACS-defined improvement

  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);

  week 24

Interventions

Deucravacitinib 6mg po qd DRUG

Deucravacitinib 6mg once a day for 6 months.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical Rheumatologist

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Myositis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Yirui Lian

CONTACT

+86 15037924173; 15037924173@163.com

Yuhui Li

CONTACT

+86 13811403148; liyuhui84@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start: October 5, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)