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

NCT04237987 | Unknown Phase 2

• 1 other identifier: CSAIL2
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Inflammatory Myopathy

Keywords

Interleukin-2; Cyclosporin A

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects meeting the definition of improvement (DOI)

  The primary outcome will be to compare the proportion of subjects meeting the definition of improvement (DOI) at visits 2 through 7 during the 6-month treatment period between the treatment and placebo arms. The DOI for this trial is a composite utilizing the six CSM: 3 of 6 CSM improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (a worsening measure cannot be the MMT).

  week 12

Secondary Outcomes (7)

• MMT-8

  week12 and week 24

• CDASI activity score

  week12 and week 24

• Physician's Global Disease Activity VAS

  week 12 and week 24

• Safety and tolerability of interleukin-2 as assessed by incidence of adverse events reported and observed

  up tp 24 weeks

• Patient's Global Disease Activity VAS

  week 12 and week 24

Study Arms (2)

Interleukin-2 and ciclosporin and corticosteroid

EXPERIMENTAL

One million units of Recombinant Human Interleukin-2 (IL-2) will be administered subcutaneously every other day for 3 months. Ciclosporin and corticosteroid will be administered according to the doctor's decision. All patients were followed up for 3 months after withdraw of IL-2.

Drug: Interleukin-2; Drug: ciclosporin and corticosteroid

ciclosporin and corticosteroid

ACTIVE COMPARATOR

Ciclosporin and corticosteroid will be administered according to the doctor's decision. All patients were followed up for 6 months.

Drug: ciclosporin and corticosteroid

Interventions

Interleukin-2 DRUG

Interleukin-2 was produced by Beijing Shuanglu Pharmaceutical Co., Ltd

Also known as: Recombinant Human Interleukin-2

Interleukin-2 and ciclosporin and corticosteroid

ciclosporin and corticosteroid DRUG

ciclosporin and corticosteroid

Interleukin-2 and ciclosporin and corticosteroid; ciclosporin and corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Patients Globle Assessment, the minimum value of 10 cm visual analog scale (VAS) is 2.0 cm
• Physicians Globle Assessment, the minimum value on the 10 cm VAS scale is 2.0 cm
• Health Assessment Questionnaire (HAQ) Disability Index, with a minimum value of 0.25
• At least one muscle enzyme \[including creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\] High, the lowest level is 1.3 x upper limit normal
• Global Extra-muscle Disease Activity Score, with a minimum of 1.0 cm on the 10 cm VAS scale \[This measure is a comprehensive assessment by the physician based on an assessment of the physique, skin, bone, gastrointestinal, lung and heart scale activity scores Myositis Disease Activity Assessment Tool (MDAAT).

You may not qualify if:

• Any subject meeting any of the following criteria should be excluded:
• 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.
• Any known history of malignancy in the past 5 years (except for non-melanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
• Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
• Accept or expect to receive any live virus or bacterial vaccination within 3 months prior to the first injection of the study agent, during the study period, or within 4 months after the last injection of the study agent. Bacillus Calmette - Guerin (BCG) vaccine was inoculated within 12 months after screening.
• Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
• Men whose partners have fertility potential but are reluctant to use appropriate medically-accepted contraceptives during treatment and 12 months after the study.
• Adolescents with DM or PM, myositis overlaps with another connective tissue disease.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (1)

• Bohan A, Peter JB, Bowman RL, Pearson CM. Computer-assisted analysis of 153 patients with polymyositis and dermatomyositis. Medicine (Baltimore). 1977 Jul;56(4):255-86. doi: 10.1097/00005792-197707000-00001. No abstract available.

  PMID: 327194 RESULT

MeSH Terms

Conditions

Myositis

Interventions

Interleukin-2; aldesleukin; Cyclosporine; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Zhanguo Li

  Peking University Institute of Rheuamotology and Immunology

  STUDY CHAIR

Central Study Contacts

MIAO MIAO

CONTACT

8618810024336; miao18734897489@126.com

Jing He

CONTACT

8618611707347; hejing1105@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: January 21, 2020
• Primary Completion: January 8, 2021
• Study Completion: April 8, 2021
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share