The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study

NCT ID: NCT06504420

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2027-12-30

Brief Summary

This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.

Conditions

Primary Antiphospholipid Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sirolimus

Sirolimus 1.5mg po. QD

Group Type: EXPERIMENTAL

Sirolimus

Intervention Type: DRUG

Subjects will receive Sirolimus 1.5mg/d for 48 weeks in addition to their ongoing APS treatment regimen

placeobo

Sirolimus placebo 1.5mg po. QD

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will receive Placebo 1.5mg/d for first 24 weeks and Sirolimus 1.5mg/d for next 24 weeks in addition to their ongoing APS treatment regimen

Interventions

Sirolimus

Subjects will receive Sirolimus 1.5mg/d for 48 weeks in addition to their ongoing APS treatment regimen

Intervention Type: DRUG

Placebo

Subjects will receive Placebo 1.5mg/d for first 24 weeks and Sirolimus 1.5mg/d for next 24 weeks in addition to their ongoing APS treatment regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Understand and sign the informed consent form

2. Male or Female

3. aged 18-70 at the time of screening visit

4. Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS

5. With the stable combination therapy

Exclusion Criteria

1. history of serious adverse events or contraindication to Sirolimus

2. Catastrophic APS within 90 days

3. Acute thrombosis within 30 days

4. ≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases

5. Historically positive HIV test or test positive at screening for HIV

6. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)

7. Surgery treatment within one month

8. History of malignant neoplasm within the last 5 years

9. White blood cell counts<3×10*9/L

10. Abnormal Liver function tests: ALT or AST ≥ 1.5 times the upper limit of the normal value, and total bilirubin and blood lipids ≥ 2 times the upper limit of the normal value

11. Pregnant or pregnancy preparation or breastfeed

12. Any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhanguo Li

Department of Rheumatology and immunology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhanguo Li

Role: STUDY_DIRECTOR

Peking university peoples hospital

Central Contacts

Liling Xu, Ph.D

Role: CONTACT

xuliling1079@163.com

+86 010 88324173

Other Identifiers

20240125

Identifier Type: -

Identifier Source: org_study_id