Deucravacitinib for adults with idiopathic inflammatory myopathies

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

This trial will try daily deucravacitinib 6 mg for six months to see if it helps adults with active idiopathic inflammatory myopathies who haven't responded to standard treatments.

Quick facts

• Study type: Observational
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: Deucravacitinib
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07564271 on ClinicalTrials.gov

What this trial studies

This is a single-center, open-label, prospective study enrolling adults (18–75) with active idiopathic inflammatory myopathies who meet Bohan & Peter or ACR/EULAR 2017 diagnostic criteria. Participants will receive deucravacitinib 6 mg orally once daily for six months with regular clinical and laboratory follow-up. Outcomes include patient and physician global VAS, MMT-8, HAQ, creatine kinase, and changes in immune cell subsets and cytokine profiles, with monitoring for safety and adverse events. Patients with prior JAK inhibitor exposure, active infections, severe hepatic/renal dysfunction, other systemic autoimmune diseases, or who are pregnant/lactating are excluded.

Who should consider this trial

Good fit: Adults aged 18–75 with active idiopathic inflammatory myopathies meeting standard diagnostic criteria who have inadequate response or intolerance to glucocorticoids or immunosuppressants and no prior JAK inhibitor use.

Not a fit: Patients with other systemic autoimmune diseases, severe liver or kidney dysfunction, active infections, prior JAK inhibitor exposure, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If effective, deucravacitinib could reduce muscle and skin inflammation and improve strength and daily function in patients with active IIMs who have not responded to conventional therapy.

How similar studies have performed: Broadly, JAK-pathway inhibition has shown promise in small studies and case reports for inflammatory myopathies, but deucravacitinib specifically is relatively untested in this condition.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Department of Rheumatology and Immunology, Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yirui Lian

Conditions Idiopathic Inflammatory Myopathies