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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 July 2024
• Main ID: NCT05605665
• Date of registration: 29/10/2022
• Prospective Registration: Yes
• Primary sponsor: Peking University People's Hospital
• Public title: Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
• Scientific title: Therapeutic Effect of Low Dose IL-2 Combined With Rapamycin in on sjögren's Syndrome
• Date of first enrolment: December 5, 2022
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05605665
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Zhanguo Li
• Affiliation: Peking university peoples hospital

Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sjögren's Syndrome

Intervention(s)

Drug: rapamycin

Drug: low-dose interleukin-2

Primary Outcome(s)

Proportion of Treg cells in peripheral blood [Time Frame: week 12]

Secondary Outcome(s)

Patient's Global Disease Activity VAS, (potential score 0 - 80) [Time Frame: week 12]

Physician's Global Disease Activity VAS, (potential score 0 - 10) [Time Frame: week 12]

ESSDAI [potential score 0 - 123] [Time Frame: week 12]

Rate of Participants with adverse effects associated with experimental drugs [Time Frame: week 12]

Secondary ID(s)

Rapa-IL2-SS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors