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Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia

RecruitingPhase 2, Phase 3Ages 18 Years - 65 YearsAllChinese SLE Treatment And Research Group
NCT07657793 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if sirolimus, added to standard background therapy (corticosteroids and hydroxychloroquine), works to treat systemic lupus erythematosus-associated immune thrombocytopenia (SLE-ITP) in adults aged 18 to 65 years. The study also aims to evaluate the long-term effectiveness and safety of sirolimus over 48 weeks. The main questions it aims to answer are: 1. Does sirolimus increase the overall response rate (complete or partial remission of thrombocytopenia) at 24 weeks compared with placebo? 2. The safety issues when taking sirolimus over 24 weeks (Phase 1) and up to 48 weeks (Phase 2). 3. How long does the treatment effect last, and what is the relapse rate during open-label extension? In Phase 1 (first 24 weeks), researchers will compare sirolimus to a placebo (an identical-looking capsule containing no active drug) to see if sirolimus works t

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📋 Eligibility rules (as published)
Inclusion Criteria: Age ≥ 18 and \< 65 years 1. Meet 2012 SLICC or 2019 EULAR/ACR criteria for systemic lupus erythematosus 2. Meet ITP diagnostic criteria: platelet count ≤ 30×10\^9/L, or ≤ 50×10\^9/L with bleeding tendency 3. At least two CBC tests showing thrombocytopenia 4. Bone marrow smear showing megakaryocyte maturation disorder 5. Willing to sign informed consent form Exclusion Criteria: 1. Other causes of thrombocytopenia 2. Refractory SLE-ITP (no partial response after 3 months of high-dose steroids or immunosuppressants) 3. Use of rituximab within 6 months 4. Severe organ involvement (e.g., proteinuria \> 1g/24h, CNS involvement, cardiac/GI involvement) 5. Other autoimmune diseases (except Sjögren's syndrome) 6. Malignancy 7. Active infections (HIV, HBV, HCV, syphilis) 8. Severe liver or kidney dysfunction 9. Splenomegaly 10. Pregnancy or breastfeeding 11. Contraindications to study drugs 12. Unhealed major wounds or incisions 13. Judged unsuitable by investigator
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What it tests

  • Sirolimus
  • Placebo
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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