Not Yet RecruitingPhase 2

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

70 participantsStarted 2024-10-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Understand and sign the informed consent form
✓. Male or Female
✓. aged 18-70 at the time of screening visit
✓. Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS
✓. With the stable combination therapy

Exclusion criteria

✕. history of serious adverse events or contraindication to Sirolimus
✕. Catastrophic APS within 90 days
✕. Acute thrombosis within 30 days
✕. ≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases
✕. Historically positive HIV test or test positive at screening for HIV
✕. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)
✕. Surgery treatment within one month
✕. History of malignant neoplasm within the last 5 years

What they're measuring

Complete response(CR) rate at week 24

Timeframe: week 24

Partial response (PR) rate at week 24

Timeframe: week 24

Trial details

NCT IDNCT06504420

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Liling Xu, Ph.D

+86 010 88324173 xuliling1079@163.com

View on ClinicalTrials.gov More Primary Antiphospholipid Syndrome trials