Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome

December 2, 2022 updated by: Zhanguo Li, Peking University People's Hospital

Therapeutic Effect of Low Dose IL-2 Combined With Rapamycin in on sjögren's Syndrome

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, and aged 18-70 at the time of screening visit.
  2. Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
  3. If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
  4. Disease activity: ESSDAI≥4 points.
  5. The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
  6. 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:

  1. Severe chronic liver, kidney and heart dysfunction.
  2. Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
  3. Patients with tumor and tumor history.
  4. Chronic respiratory failure.
  5. Patients who are ineffective in high-dose hormone pulse therapy.
  6. Those who use rituximab or other biological agents within 3 months.
  7. Patients with active tuberculosis infection or potential tuberculosis infection.
  8. There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-dose interleukin-2
One million IU of IL-2 was injected subcutaneously once every other day for 4 weeks.
Drug: low-dose interleukin-2
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once every other day, for 4 weeks.
Other Names:
  • Recombinant Human Interleukin-2
Active Comparator: Rapamycin
Rapamycin 0.5ml once per day for 4 weeks.
Drug: rapamycin
Rapamycin 0.5ml was taken orally once per day
Other Names:
  • sirolimus
Experimental: Low-dose interleukin-2 and rapamycin
One million IU of IL-2 was injected subcutaneously once every other day and rapamycin 0.5ml once per day for 4 weeks.
Drug: low-dose interleukin-2
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once every other day, for 4 weeks.
Other Names:
  • Recombinant Human Interleukin-2
Drug: rapamycin
Rapamycin 0.5ml was taken orally once per day
Other Names:
  • sirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Treg cells in peripheral blood
Time Frame: week 4
Proportion of Treg cells in peripheral blood will be detected by flowcytometry
week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ESSDAI [potential score 0 - 123]
Time Frame: week 4
ESSDAI is [European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index]. Higher scores mean a worse outcome.
week 4
Physician's Global Disease Activity VAS, (potential score 0 - 10)
Time Frame: week 4
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.
week 4
Patient's Global Disease Activity VAS, (potential score 0 - 80)
Time Frame: week 4
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.
week 4
Rate of Participants with adverse effects associated with experimental drugs
Time Frame: week 4
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.
week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Director: Zhanguo Li, Peking University Peoples Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 29, 2022

First Submitted That Met QC Criteria

October 29, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rapa-IL2-SS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sjögren's Syndrome

Clinical Trials on low-dose interleukin-2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe