Interleukin-2 on Active Dermatomyositis

NCT05495321 | Enrolling By Invitation Phase 3

• 1 other identifier: IIMIL2
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this paper is to explore the effect of low-dose IL-2 on refractory dermatomyositis and immunological indexes.

Conditions

Dermatomyositis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving minimal improvement (TIS≥20).

  The primary outcome will be to compare the proportion of subjects achieving minimal improvement (TIS≥20). The TIS (total improvement score) is the sum of all 6 improvement scores associated with the change in each core set measure. A total improvement score of ≥20 represents minimal improvement, a score of ≥40 represents moderate improvement, and a score of ≥60 represents major improvement.

  week 12

Secondary Outcomes (12)

• MMT-8 (Manual Muscle Testing), (potential score 0 - 80);

  week12 and 24

• CDASI activity score (cutaneous dermatomyositis disease area and severity index), (potential score 0-100 for cutaneous dermatomyositis disease area and 0-32 for severity index);

  week12 and 24

• Physician's Global Disease Activity VAS, (potential score 0 - 10);

  week12 and 24

• Patient's Global Disease Activity VAS, (potential score 0 - 80);

  week 12 and 24

• Health assessment question, (potential score 0 - 3);

  week 12 and 24

Study Arms (2)

low-dose IL-2

EXPERIMENTAL

The first stage (double-blind treatment period): One million IU of IL-2 was injected subcutaneously once every other day for 12 weeks. The second stage (open treatment period): One million IU of IL-2 was injected subcutaneously once every other day for 12 weeks.

Drug: Interleukin-2

Placebo

PLACEBO COMPARATOR

The first stage (double-blind treatment period): Placebo was injected subcutaneously once every other day for 12 weeks. The second stage (open treatment period): One million IU of IL-2 was injected subcutaneously once every other day for 12 weeks.

Drug: Interleukin-2

Interventions

Interleukin-2 DRUG

low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU once every other day, for 6 months.

Also known as: Recombinant Human Interleukin-2

Placebo; low-dose IL-2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old (including 18 and 75 years old);
• The diagnosis of dermatomyositis conforms to Bohan/Peter Recommendation in 1975 or EULAR/ACR Classification Standard in 2017.
• Active myositis was defined by baseline Manual Muscle Testing (MMT-8) no greater than 125/150 and at least two additional abnormal CSMs. To allow the enrolment of patients with active DM with a moderate to severe rash who may not meet the MMT-8 criterion noted above, patients with DM could be enrolled if their cutaneous VAS score on the Myositis Disease Activity Assessment Tool (MDAAT) was ≥3cm on the 10cm VAS scale and at least three of the five CSMs were abnormal (excluding the MMT-8).
• Abnormal CSMs include:
• \. patients global assessment (PGA), the minimum value of 10 cm visual analog scale (VAS) is 2.0 cm
• \. Physicians global assessment (PhGA), the minimum value on the 10 cm VAS scale is 2.0 cm
• \. Health Assessment Questionnaire (HAQ), 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 \[This measure is a comprehensive assessment by the physician based on an assessment of the physique, skin, bone, gastrointestinal, lung and heart scale activity scores,named Myositis Disease Activity Assessment Tool (MDAAT)\].
• \. Manual Muscle Testing (MMT-8) no greater than 125/150.
• The dose of glucocorticoid (equivalent to prednisone) was less than 0.5mg/kg/d within 4 weeks before joining the group, and/or there were no new immunosuppressants (cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, methotrexate, etc.) within 12 weeks, and the dose was stable for 4 weeks.
• Voluntary signing of informed consent: When participating in the trial, the patient must be given a written notice of consent, and hope that the patient can comply with the requirements of the study follow-up plan and other protocols.
• Agree to adopt effective contraceptive measures during the study period (women of childbearing age).

You may not qualify if:

• Any subject meeting any of the following criteria should be excluded:
• Received intravenous glucocorticoid (\> 1 mg/kg/d) within 4 weeks;
• Serious complications: including (1). heart failure (≥ NYHA III); (2). renal insufficiency (creatinine clearance rate ≤30 ml/min); (3). liver insufficiency (excluding serum ALT or AST caused by dermatomyositis, or total bilirubin greater than normal upper limit), (4). hemoglobin \< 80g/L, E. platelet count \< 60.
• Dermatomyositis patients with other connective tissue diseases or tumors;
• Allergic constitution or allergic to multiple drugs;
• Those who are in the period of acute and chronic infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), or are hospitalized for infection, or use intravenous antibiotics to treat infection 2 months before the first treatment, or have a history of active tuberculosis in the past;
• Those who are positive for hepatitis B surface antigen or hepatitis C antibody;
• Persons with mental illness or other reasons who cannot cooperate with treatment.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Dermatomyositis

Interventions

Interleukin-2; aldesleukin

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Zhanguo Li

  Peking University People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: August 10, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2022

Record last verified: 2022-12

Locations

CN (1)