UnknownPhase 2

Low-dose Interleukin-2 in Combination With Standard Therapy on Idiopathic Inflammatory Myopathy

20 participantsStarted 2020-01-21

Plain-language summary

This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) and cyclosporin a (CSA) on idiopathic inflammatory myopathy (IIM)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female \>18 years of age at screening visits
✓. Diagnostics meet the 1975 Bohan recommendations
✓. Failed at least 3 months treatment with hydroxychloroquine;
✓. New onset patients or recurrent patients after reduction of medication
✓. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
✓. Active Disease means active skin disease or active muscle myositis. Active skin disease as defined by a CDASI score of at least 5. The active muscle myositis defined by the baseline hand muscle strength test (MMT-8) does not exceed 142/150, wtih at least 2 additional CSMs meet the criteria specified below:

Exclusion criteria

✕. Use rituximab or other monoclonal antibodies within 6 months.
✕. Received high doses of glucocorticoid (\>0.5 mg/kg/d) within 1 month.
✕. Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum ALT or AST greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit)
✕. Other serious, progressive or uncontrollable hematology, gastrointestinal, endocrine, pulmonary, cardiac, neurological or brain disorders (including demyelinating diseases such as multiple sclerosis).
✕. Known allergies, hyperreactivity or intolerance of IL-2 or its excipients.
✕. Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
✕. Chest imaging showed abnormalities in malignant tumors or current active infections (including tuberculosis) within 3 months prior to the first use of the study drug.
✕. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.

What they're measuring

Proportion of subjects meeting the definition of improvement (DOI)

Timeframe: week 12

Trial details

NCT IDNCT04237987

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-08

Contact for this trial

MIAO MIAO

8618810024336 miao18734897489@126.com

View on ClinicalTrials.gov More Inflammatory Myopathy trials