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

Sjögren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605665
• Other study ID #: Rapa-IL2-SS
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 5, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Peking University People's Hospital
• Contact: Miao Miao
• Phone: +86-10-8832
• Email: miao18734897489[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

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.
• rapamycin
Rapamycin 0.5ml was taken orally once per day

Locations

Country	Name	City	State
China	Peking university people's hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Treg cells in peripheral blood	Proportion of Treg cells in peripheral blood will be detected by flowcytometry	week 4
Secondary	ESSDAI [potential score 0 - 123]	ESSDAI is [European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index]. Higher scores mean a worse outcome.	week 4
Secondary	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 4
Secondary	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 4
Secondary	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 4