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

NCT05605665 | Completed Phase 1

• 1 other identifier: Rapa-IL2-SS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of Treg cells in peripheral blood

  Proportion of Treg cells in peripheral blood will be detected by flowcytometry

  week 12

Secondary Outcomes (4)

• ESSDAI [potential score 0 - 123]

  week 12

• Physician's Global Disease Activity VAS, (potential score 0 - 10)

  week 12

• Patient's Global Disease Activity VAS, (potential score 0 - 80)

  week 12

• Rate of Participants with adverse effects associated with experimental drugs

  week 12

Study Arms (3)

Low-dose interleukin-2

ACTIVE COMPARATOR

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

Drug: low-dose interleukin-2

Rapamycin

ACTIVE COMPARATOR

Rapamycin 0.5ml once per day for 12 weeks.

Drug: rapamycin

Low-dose interleukin-2 and rapamycin

EXPERIMENTAL

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

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

Interventions

low-dose interleukin-2 DRUG

low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU once twice a week, for 12 weeks.

Also known as: Recombinant Human Interleukin-2

Low-dose interleukin-2; Low-dose interleukin-2 and rapamycin

rapamycin DRUG

Rapamycin 0.5ml was taken orally once per day

Also known as: sirolimus

Low-dose interleukin-2 and rapamycin; Rapamycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, and aged 18-70 at the time of screening visit.
• Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
• If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
• Disease activity: ESSDAI≥4 points.
• The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
• 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.

You may not qualify if:

• Severe chronic liver, kidney and heart dysfunction.
• Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
• Patients with tumor and tumor history.
• Chronic respiratory failure.
• Patients who are ineffective in high-dose hormone pulse therapy.
• Those who use rituximab or other biological agents within 3 months.
• Patients with active tuberculosis infection or potential tuberculosis infection.
• There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Interleukin-2; aldesleukin; Sirolimus

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Macrolides; Lactones; Organic Chemicals

Study Officials

• Zhanguo Li

  Peking university peoples hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2022
• First Posted: November 4, 2022
• Study Start: December 5, 2022
• Primary Completion: December 30, 2023
• Study Completion: March 31, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)