NCT07564271 Clinical Characteristics and Mechanism Research of Deucravacitinib in the Idiopathic Inflammatory Myopathies
| NCT ID | NCT07564271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Idiopathic Inflammatory Myopathies (IIMs) |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-10-05 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2025-10-05 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07564271 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Idiopathic Inflammatory Myopathies (IIMs). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07564271 currently recruiting?
Yes, NCT07564271 is actively recruiting participants. Contact the research team at 15037924173@163.com for enrollment information.
Where is the NCT07564271 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07564271 clinical trial?
NCT07564271 is sponsored by Peking University People's Hospital. The trial plans to enroll 10 participants.