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Inflammatory MyopathyPhase 2NCT04237987

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

A Phase 2 study testing Interleukin-2 and ciclosporin and corticosteroid in people with Inflammatory Myopathy, run by Peking University People's Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inflammatory Myopathy
What is being tested?
Interleukin-2 and ciclosporin and corticosteroid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
21 Jan 2020to 8 Apr 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet.

MIAO MIAO contact

8618810024336

miao18734897489@126.com

Jing He contact

8618611707347

hejing1105@126.com

About this study

Official title: A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Low-dose Interleukin-2 in Combination With Standard Therapy Compared to Standard Therapy Alone in Adults With Active Idiopathic Inflammatory Myopathy

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)

Read the detailed description

The investigators designed a radomized control study. Adults with active IIM will be enrolled. IIM is defined as Dermatomyositis (DM) or Polymyositis (PM), meeting the Bohan \& Peter (1975) diagnostic criteria for definite or probable DM or PM. Patients will be randomly divided into 2 groups arranged by registration order. One million units of Recombinant Human Interleukin-2 (rhIL-2) was administered subcutaneously every other day for 3 months. All patients were followed up for 3 months after withdraw of IL-2.

Being tested
Interleukin-2, ciclosporin and corticosteroid
Keywords
Interleukin-2, Cyclosporin A
Medical subject headings
Myositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interleukin-2Drug

    Also called Recombinant Human Interleukin-2

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

  • ciclosporin and corticosteroidDrug

    ciclosporin and corticosteroid

Study groups in NCT04237987
Study groupRoleWhat they receive
Interleukin-2 and ciclosporin and corticosteroidExperimentalOne 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.
Receives: Drug: Interleukin-2; Drug: ciclosporin and corticosteroid
ciclosporin and corticosteroidActive comparatorCiclosporin and corticosteroid will be administered according to the doctor's decision. All patients were followed up for 6 months.
Receives: Drug: ciclosporin and corticosteroid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: week 12

Secondary outcomes (7)

  1. MMT-8

    MMT-8; a set of 8 designated muscles tested bilaterally [potential score 0 - 150]

    Measured: week12 and week 24

  2. CDASI activity score

    The CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM patients for use in clinical practice or clinical/therapeutic studies. Disease involvement in 15 different anatomical locations is rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia are also captured. Disease activity is scored from 0 to 100; higher scores indicate greater disease severity.

    Measured: week12 and week 24

  3. Physician's Global Disease Activity VAS

    Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis).

    Measured: week 12 and week 24

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

    we will report frequency of adverse events

    Measured: up tp 24 weeks

  5. Patient's Global Disease Activity VAS

    Patient's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis).

    Measured: week 12 and week 24

  6. 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 3 after the 3-month treatment period. The DOI for this trial is a composite utilizing the six core set measures (CSM): 3 of 6 CSM improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (a worsening measure cannot be the MMT).

    Measured: week12 and week 24

  7. Foxp3+Treg cells: change in percentage of total lymphocytes

    Treg refers to regulatory T cells

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start21 Jan 2020 (estimated)
  3. Primary completion8 Jan 2021 (estimated)
  4. Study completion8 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04237987
Sponsor's protocol ID
CSAIL2
Status last verified
Jan 2020
First submitted
19 Jan 2020
Last updated
23 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 327194

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interleukin-2 and ciclosporin and corticosteroid in people with Inflammatory Myopathy, run by Peking University People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact MIAO MIAO (8618810024336, miao18734897489@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects meeting the definition of improvement (DOI) (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04237987, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.

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