Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial and Open-Label Extension Study of Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia
Run by Chinese SLE Treatment And Research Group · NCT07657793 · Data updated 2026-11-12
This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | Chinese SLE Treatment And Research Group Academic / other |
| Drugs / interventions | rituximab, prednisone |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 7, 2026 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2029 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07657793 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with SLE meeting 2012 SLICC or 2019 EULAR/ACR criteria and ITP criteria defined by low platelets or bleeding risk.
✕Probably not a fit
Patients without a platelet response or with safety concerns may not benefit from sirolimus.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2/3 study evaluates sirolimus in adults aged 18–65 with SLE-associated ITP who receive standard prednisone and hydroxychloroquine. Participants are randomized to sirolimus or placebo for the initial 24 weeks, with long-term follow-up up to 48 weeks to assess lasting effects and safety. The study focuses on overall response rate at 24 weeks, safety of sirolimus over 24 to 48 weeks, and relapse rates during an open-label extension. Outcomes include platelet responses and incidence of adverse events in addition to ongoing disease activity.
Why it matters
Potential benefit: If successful, sirolimus could improve platelet counts and disease control for patients with SLE-ITP beyond standard therapy.
How similar studies have gone: Previous studies in similar autoimmune contexts have shown potential signal with mTOR inhibitors, but results for SLE-ITP are still being explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Liying Peng
- Email: liying_peng@qq.com
- Phone: 86 010 69159958
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.