DermatomyositisPhase 3NCT05495321
Interleukin-2 on Active Dermatomyositis
A Phase 3 study testing Interleukin-2 in people with Dermatomyositis, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this paper is to explore the effect of low-dose IL-2 on refractory dermatomyositis and immunological indexes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Sep 2026
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 1. patients global assessment (PGA), the minimum value of 10 cm visual analog scale (VAS) is 2.0 cm
- 2. Physicians global assessment (PhGA), the minimum value on the 10 cm VAS scale is 2.0 cm
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- 3. Health Assessment Questionnaire (HAQ), with a minimum value of 0.25
- 4. 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
- 5. 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)].
- 6. 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university people's hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Therapeutic Effect of Interleukin-2 on Active Dermatomyositis: A Multicenter, Randomised, Double-blind, Placebo-controlled Trial
The purpose of this paper is to explore the effect of low-dose IL-2 on refractory dermatomyositis and immunological indexes.
Read the detailed description
A randomized, double-blind, placebo-controlled, multicenter clinical trial was designed. Patients were treated with low-dose IL-2 regularly to explore its efficacy and safety. The improvement of clinical and laboratory indexes was evaluated. Changes of immune cell subsets and cytokines were monitored.
- Conditions
- Dermatomyositis
- Being tested
- Interleukin-2
- Medical subject headings
- Dermatomyositis
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
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once every other day, for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 12
Secondary outcomes (12)
MMT-8 (Manual Muscle Testing), (potential score 0 - 80);
MMT-8 is a set of 8 designated muscles tested unilaterally; test on right side (use left side if right side cannot be tested). Higher scores mean a better outcome.
Measured: 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);
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. Higher scores mean a worse outcome.
Measured: week12 and 24
Physician's Global Disease Activity VAS, (potential score 0 - 10);
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). Higher scores mean a worse outcome.
Measured: week12 and 24
Patient's Global Disease Activity VAS, (potential score 0 - 80);
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). Higher scores mean a worse outcome.
Measured: week 12 and 24
Health assessment question, (potential score 0 - 3);
Patients reported how their illness affects their ability to function in daily life , Higher scores mean a better outcome.
Measured: week 12 and 24
Myositis disease activity assessment tool (MDAAT) - 2005, VERSION 2
This is a combined tool that captures the physician's assessment of disease activity of various organ systems using (1) the 0-4 scale described below and (2) a visual analog scale (VAS) [potential score 0 - 10]. Please assess the clinical features (items 1-26) of each organ system. Higher scores mean a worse outcome.
Measured: week 12 and 24
CD4 T cells
number and proportion of CD4 T cells in peripheral blood.
Measured: week 12 and 24
Serum cytokines
concentration of serum cytokines
Measured: week 12 and 24
glucocorticoid dosage
Daily dosage of glucocorticoid
Measured: week 12 and 24
Rate of Participants with adverse effects associated with experimental drugs
Adverse effects include fever, rash, abnormal liver function, rate of new-onset infection and any abnormal measures associated with low-dose IL-2 therapy.
Measured: up to 24 weeks
Proportion of subjects meeting the definition of improvement (DOI)
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: week12 and 24
Number 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.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Dec 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhanguo Li, Peking University People's Hospital
- Investigators
- Zhanguo Li, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495321
- Sponsor's protocol ID
- IIMIL2
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Interleukin-2 on Active Dermatomyositis: A Multicenter, Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05495321
- Acronym / sponsor ID
- IIMIL2
- Conditions
- Dermatomyositis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this paper is to explore the effect of low-dose IL-2 on refractory dermatomyositis and immunological indexes.
Detailed description
A randomized, double-blind, placebo-controlled, multicenter clinical trial was designed. Patients were treated with low-dose IL-2 regularly to explore its efficacy and safety. The improvement of clinical and laboratory indexes was evaluated. Changes of immune cell subsets and cytokines were monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose IL-2 | Experimental | Drug: Interleukin-2The 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. |
| Placebo | Placebo comparator | Drug: Interleukin-2The 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin-2Also: Recombinant Human Interleukin-2low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once every other day, for 6 months. | Drug | Placebo, low-dose IL-2 |
Primary outcome
Proportion of subjects achieving minimal improvement (TIS≥20).
Time frame: week 12
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.
12 secondary outcomes
MMT-8 (Manual Muscle Testing), (potential score 0 - 80);
Time frame: 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);
Time frame: week12 and 24
Physician's Global Disease Activity VAS, (potential score 0 - 10);
Time frame: week12 and 24
Patient's Global Disease Activity VAS, (potential score 0 - 80);
Time frame: week 12 and 24
Health assessment question, (potential score 0 - 3);
Time frame: week 12 and 24
Myositis disease activity assessment tool (MDAAT) - 2005, VERSION 2
Time frame: week 12 and 24
CD4 T cells
Time frame: week 12 and 24
Serum cytokines
Time frame: week 12 and 24
glucocorticoid dosage
Time frame: week 12 and 24
Rate of Participants with adverse effects associated with experimental drugs
Time frame: up to 24 weeks
Proportion of subjects meeting the definition of improvement (DOI)
Time frame: week12 and 24
Number of subjects achieving minimal improvement (TIS≥20).
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanguo Li study director
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interleukin-2 in people with Dermatomyositis, run by Peking University People's Hospital at 1 site in China.
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 13 inclusion and 8 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 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving minimal improvement (TIS≥20). (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2022.