Back to resultsLow-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
Primary Purpose
Sjögren's Syndrome
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
low-dose interleukin-2
rapamycin
Sponsored by
About this trial
This is an interventional treatment trial for Sjögren's Syndrome
Eligibility Criteria
Inclusion Criteria: Male or female, and aged 18-70 at the time of screening visit. Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria. If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment. Disease activity: ESSDAI≥4 points. The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline. The written informed consent form approved by the Ethics Committee of Peking University People's Hospital was signed and dated by the subject or legal representative. Exclusion Criteria: Severe chronic liver, kidney and heart dysfunction. Severe drug-resistant bacterial infections, such as bacteremia and septicemia. Patients with tumor and tumor history. Chronic respiratory failure. Patients who are ineffective in high-dose hormone pulse therapy. Those who use rituximab or other biological agents within 3 months. Patients with active tuberculosis infection or potential tuberculosis infection. There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.
Sites / Locations
- Peking university people's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Low-dose interleukin-2
Rapamycin
Low-dose interleukin-2 and rapamycin
Arm Description
One million IU of IL-2 was injected subcutaneously once every other day for 4 weeks.
Rapamycin 0.5ml once per day for 4 weeks.
One million IU of IL-2 was injected subcutaneously once every other day and rapamycin 0.5ml once per day for 4 weeks.
Outcomes
Primary Outcome Measures
Proportion of Treg cells in peripheral blood
Proportion of Treg cells in peripheral blood will be detected by flowcytometry
Secondary Outcome Measures
ESSDAI [potential score 0 - 123]
ESSDAI is [European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index]. Higher scores mean a worse outcome.
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.
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.
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, and oral ulcer, rash, hypertension, anemia, arthralgia, diarrhea and any abnormal measures associated with rapamycin therapy.
Full Information
NCT ID
NCT05605665
First Posted
October 29, 2022
Last Updated
December 2, 2022
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05605665
Brief Title
Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
Official Title
Therapeutic Effect of Low Dose IL-2 Combined With Rapamycin in on sjögren's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome
Detailed Description
A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjögren's Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-dose interleukin-2
Arm Type
Active Comparator
Arm Description
One million IU of IL-2 was injected subcutaneously once every other day for 4 weeks.
Arm Title
Rapamycin
Arm Type
Active Comparator
Arm Description
Rapamycin 0.5ml once per day for 4 weeks.
Arm Title
Low-dose interleukin-2 and rapamycin
Arm Type
Experimental
Arm Description
One million IU of IL-2 was injected subcutaneously once every other day and rapamycin 0.5ml once per day for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
low-dose interleukin-2
Other Intervention Name(s)
Recombinant Human Interleukin-2
Intervention Description
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once every other day, for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
rapamycin
Other Intervention Name(s)
sirolimus
Intervention Description
Rapamycin 0.5ml was taken orally once per day
Primary Outcome Measure Information:
Title
Proportion of Treg cells in peripheral blood
Description
Proportion of Treg cells in peripheral blood will be detected by flowcytometry
Time Frame
week 4
Secondary Outcome Measure Information:
Title
ESSDAI [potential score 0 - 123]
Description
ESSDAI is [European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index]. Higher scores mean a worse outcome.
Time Frame
week 4
Title
Physician's Global Disease Activity VAS, (potential score 0 - 10)
Description
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.
Time Frame
week 4
Title
Patient's Global Disease Activity VAS, (potential score 0 - 80)
Description
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.
Time Frame
week 4
Title
Rate of Participants with adverse effects associated with experimental drugs
Description
Adverse effects include fever, rash, abnormal liver function, rate of new-onset infection and any abnormal measures associated with low-dose IL-2 therapy, and oral ulcer, rash, hypertension, anemia, arthralgia, diarrhea and any abnormal measures associated with rapamycin therapy.
Time Frame
week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, and aged 18-70 at the time of screening visit.
Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
Disease activity: ESSDAI≥4 points.
The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
The written informed consent form approved by the Ethics Committee of Peking University People's Hospital was signed and dated by the subject or legal representative.
Exclusion Criteria:
Severe chronic liver, kidney and heart dysfunction.
Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
Patients with tumor and tumor history.
Chronic respiratory failure.
Patients who are ineffective in high-dose hormone pulse therapy.
Those who use rituximab or other biological agents within 3 months.
Patients with active tuberculosis infection or potential tuberculosis infection.
There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miao Miao
Phone
+86-10-8832
Ext
4173
Email
miao18734897489@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li
Organizational Affiliation
Peking university peoples hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking university people's hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miao Miao
Phone
+86-10-8832
Ext
4173
Email
miao18734897489@126.com
12. IPD Sharing Statement
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Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
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