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

Phase 1

Completed

• Conditions: Sjögren's Syndrome
• Interventions: Drug: low-dose interleukin-2; Drug: rapamycin

• Registration Number: NCT05605665
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-29
• Study First Submitted QC: 2022-10-29
• Study First Posted: 2022-11-04
• Study Start: 2022-12-05
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-07
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose interleukin-2 and rapamycin	rapamycin	One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks.
Low-dose interleukin-2	low-dose interleukin-2	One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks.
Low-dose interleukin-2 and rapamycin	low-dose interleukin-2	One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks.
Rapamycin	rapamycin	Rapamycin 0.5ml once per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of Treg cells in peripheral blood	week 12	Proportion of Treg cells in peripheral blood will be detected by flowcytometry

Secondary Outcome Measures

Name	Time	Method
Patient's Global Disease Activity VAS, (potential score 0 - 80)	week 12	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	week 12	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.
ESSDAI [potential score 0 - 123]	week 12	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)	week 12	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.

Trial Locations

Locations (1)

Peking university people's hospital; 🇨🇳 Beijing, Beijing, China