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

Peking University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sjögren's Syndrome

Treatments: Drug: low-dose interleukin-2; Drug: rapamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05605665

Rapa-IL2-SS

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Low-dose interleukin-2

Active Comparator group

Description:

One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks.

Treatment:

Drug: low-dose interleukin-2

Rapamycin

Active Comparator group

Description:

Rapamycin 0.5ml once per day for 12 weeks.

Treatment:

Drug: rapamycin

Low-dose interleukin-2 and rapamycin

Experimental group

Description:

One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks.

Treatment:

Drug: rapamycin

Drug: low-dose interleukin-2