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| Name | Class |
|---|---|
| Monash University | OTHER |
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This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic lupus erythematosus.
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs. While available therapies, such as corticosteroids and immunosuppressive agents have improved the outcome of patients, there remains a significant unmet need for safe and more effective treatments. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). We hypothesized that low-dose IL-2 could be a novel therapy in active SLE patients.
This is a single center, uncontrolled, open-label study to assess the efficacy/safety of low dose IL-2 plus standard therapy in active SLE.
Methods: Each SLE patients (n=40) with Scores>=8 on the Safety of Estrogens in Lupus Erythematosus National Assessment (AELENA) version of the SLE Disease Activity Index (SLEDAI) that was refractory or relaps to glucocorticoid therapy received low-dose IL-2 (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 cycles according to the situation of the disease. The end points were safety and clinical and immunologic response.
Expected Results: This trail will define low-dose IL-2 plus standard therapy is efficacy and safety with active lupus patients, which could be relevant to the amelioration the abnormity of T help cells in SLE patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin-2 | Experimental | Interleukin-2 to treat activated SLE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin-2 | Drug | Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were SLE Responders (SRI) | SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points. | week 2，week 4，week 6，week 8，week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological Responses | Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study. | week 0 and week 10 |
| The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li, MD and PhD | Peking University Institute of Rheumatology and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology and Immunology, Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34094549 | Derived | Liang K, He J, Wei Y, Zeng Q, Gong D, Qin J, Ding H, Chen Z, Zhou P, Niu P, Chen Q, Ding C, Lu L, Chen XX, Li Z, Shen N, Yu D, Deng J. Sustained low-dose interleukin-2 therapy alleviates pathogenic humoral immunity via elevating the Tfr/Tfh ratio in lupus. Clin Transl Immunology. 2021 Jun 1;10(6):e1293. doi: 10.1002/cti2.1293. eCollection 2021. |
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All the patients showed poor efficacy at least 4 weeks of stable routine treatment at the time of enrollment. Two of the enrolled patients withdrew from the study at week 8: one changed to the belimumab treatment by personal preference; the other elected changed to the cyclophosphamide treatment to reduce the frequency of hospital visits.
Between August 2013 and May 2014,38 patients completed three cycles of recombinant human IL-2 (rhIL-2) in Dept. of Rheumatology and Immunology, Peking University People's Hospital. Patients were permitted changes in background therapy according to the treating physician's advice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interleukin-2 | Interleukin-2 to treat activated SLE. Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day break, another cycle started) for 3-6 courses according to the situation of the disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interleukin-2 | Interleukin-2 to treat activated SLE. Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Were SLE Responders (SRI) | SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points. | Posted | Number | participants | week 2，week 4，week 6，week 8，week 10 |
|
|
3 months
No serious adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IL-2 Therapy in SLE | All enrolled patients completed three cycles of recombinant human IL-2 (rhIL-2). In each cycle, 1 million IU rhIL-2 was administered subcutaneously every other day for 2 weeks, followed by a 2-week break. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jing He | Peking University People's Hospital | 86 | 1861170734 | hejing1105@126.com |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
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Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres. |
| week 0 and week 10 |
| SELENA SLEDAI Score | Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points, score> 8 means the disease is moderate-to-severe active". | week 0, week 10 |
| Number of Relapses | Relapses mean that if the patient's SELENA SLEDAI Score is lower than 4 during the treatment, while the SELENA SLEDAI Score increase after stopping using the study drugs in 3 months. | 24 weeks |
| Safety Assessment | Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage. | up to Day 180 |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Forty patients with active SLE were recruited; 38 patients completed three cycles of recombinant human IL-2 (rhIL-2). Two of the enrolled patients withdrew from the study at week 8: one changed to the belimumab treatment by personal preference; the other elected changed to the cyclophosphamide treatment to reduce the frequency of hospital visits. | Count of Participants | Participants |
|
| Region of Enrollment | Study location is in the Dept. of Rheumatology and Immunology, Peking University People's Hospital. | Number | partiipants |
|
| SELENA-SLEDAI score | All patients were SLE with moderate-to-severe disease activity (Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) > 8.The total score ranges from 0 to 105 points.The higher the points values represent the worse/serious of the disease. Generally, (SELENA-SLEDAI) > 8 means the disease is moderate-to-severe active. | Median | Standard Deviation | score |
|
|
| Secondary | Immunological Responses | Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study. | regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells | Posted | Median | Full Range | Percentage of CD4+ T cells | week 0 and week 10 |
|
|
|
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| Secondary | The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients | Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres. | Posted | Median | Full Range | g/L | week 0 and week 10 |
|
|
|
| Secondary | SELENA SLEDAI Score | Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points, score> 8 means the disease is moderate-to-severe active". | Posted | Median | Standard Deviation | score | week 0, week 10 |
|
|
|
| Secondary | Number of Relapses | Relapses mean that if the patient's SELENA SLEDAI Score is lower than 4 during the treatment, while the SELENA SLEDAI Score increase after stopping using the study drugs in 3 months. | Not Posted | Apr 2020 | 24 weeks | Participants |
| Secondary | Safety Assessment | Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage. | Not Posted | Apr 2020 | up to Day 180 | Participants |
| 0 |
| 38 |
| 5 |
| 38 |
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
|
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