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NCT Number: NCT06504420

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

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.

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Key information

Conditions

Primary Antiphospholipid Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • White blood cell counts<3×10*9/L
  • 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
  • Pregnant or pregnancy preparation or breastfeed
  • Any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects

Treatment and study plan

sirolimus

Drug

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

Placebo

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

Primary outcomes

  1. Complete response(CR) rate at week 24

    Time frame: week 24

    CR will be defined as follows: 1.No thrombosis events; 2.PLT ≥100 and with nobleeding; 3. No persistent autoimmnune haemolytic anaemia; 4. No skin ulcer; 5.No renal thrombotic microangiopathy; 5.Normal cognitive function (MoCA score ≥26）.

  2. Partial response (PR) rate at week 24

    Time frame: week 24

    PR will be defined as one of follows: 1.superficial thrombotic events;2. PLT ≥30 or increased at least 2 times of baseline and with no bleeding;3.haemoglobulin concentration normal or increased 20g/L compared to baseline; 4.50% improvement; 5. a serum creatinine level 15% abov baseline, RBCs per high-power field 50% above baseline with no casts, 50% improvement in the urinary prt:cr; 6. milde cognitive diysfunction (MoCA 9~25).

Secondary outcomes

  1. Complete response(CR) rate at week 48

    Time frame: week 48

    CR will be defined as follows: 1.No thrombosis events; 2.PLT ≥100 and with nobleeding; 3. No persistent autoimmnune haemolytic anaemia; 4. No skin ulcer; 5.No renal thrombotic microangiopathy; 5.Normal cognitive function (MoCA score ≥26）.

  2. Partial response (PR) rate at week 48

    Time frame: week 48

    PR will be defined as one of follows: 1.superficial thrombotic events;2. PLT ≥30 or increased at least 2 times of baseline and with no bleeding;3.haemoglobulin concentration normal or increased 20g/L compared to baseline; 4.50% improvement; 5. a serum creatinine level 15% abov baseline, RBCs per high-power field 50% above baseline with no casts, 50% improvement in the urinary prt:cr; 6. milde cognitive diysfunction (MoCA 9~25).

  3. Rate of Participants with adverse effects and serious adverse effects during treatment

    Time frame: baseline to week 48

    Adverse effects include fever, rash, abnormal liver function, rate of new-onset infections and any abnormal measures after recivede study drug.

Study contacts

Contact information is provided by the study sponsor or research team.

Liling Xu, Ph.D

CONTACT

[email protected]

+86 010 88324173

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Randomized, Multicenter, Double-blind, Placeobo-control Study of Sirolimus for Primary Antiphospholipid Syndrome Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 16, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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