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

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: Completed
• Conditions: Sjögren's Syndrome
• Intervention / Treatment: Drug: rapamycin; Drug: low-dose interleukin-2

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 (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-dose interleukin-2; One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks.	Drug: low-dose interleukin-2; low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once twice a week, for 12 weeks.; Other Names: Recombinant Human Interleukin-2
Active Comparator: Rapamycin; Rapamycin 0.5ml once per day for 12 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 twice a week and rapamycin 0.5ml once per day for 12 weeks.	Drug: rapamycin; Rapamycin 0.5ml was taken orally once per day; Other Names: sirolimus; Drug: low-dose interleukin-2; low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once twice a week, for 12 weeks.; Other Names: Recombinant Human Interleukin-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Treg cells in peripheral blood	Proportion of Treg cells in peripheral blood will be detected by flowcytometry	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESSDAI [potential score 0 - 123]	ESSDAI is [European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index]. Higher scores mean a worse outcome.	week 12
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.	week 12
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.	week 12
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.	week 12

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Director: Zhanguo Li, Peking University Peoples Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): March 31, 2024

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): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Aldesleukin; Sirolimus; Interleukin-2
• 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