Sirolimus Trial for Low Platelets Caused by Lupus in Adults
Tests sirolimus, or a placebo, in adults with lupus and low platelets.
Plain-language title generated from the registry record
Registry title: Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic lupus erythematosus who also have immune thrombocytopenia (low platelet counts). It tests sirolimus added to standard treatment.
- Age
- 18 to under 65 years
- Sex
- All sexes can join.
- Disease stage
- Lupus that meets the 2012 SLICC or 2019 EULAR/ACR criteria, with immune thrombocytopenia: platelet count ≤ 30×10^9/L, or ≤ 50×10^9/L with a tendency to bleed. At least two blood counts show low platelets. A bone marrow smear shows a maturation problem of megakaryocytes.
- Earlier treatment
- People cannot join if they used rituximab within 6 months. People cannot join if there was no partial response after 3 months of high-dose steroids or immunosuppressants.
Main reasons for not taking part
- Other causes of low platelets
- Severe organ involvement, such as proteinuria > 1g/24h, or brain, heart or gut involvement
- Other autoimmune diseases, except Sjögren's syndrome
- Cancer, or active infections (HIV, HBV, HCV, syphilis)
- Pregnancy or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07657793, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaContact: Liying PengTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chinese SLE Treatment And Research Group
- Trial code
- NCT07657793
- Record updated
- 18 June 2026
- Original description
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.Read full original descriptionShow less
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
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 to treat SLE-ITP when both groups also receive standardized prednisone and hydroxychloroquine. In Phase 2 (weeks 24 to 48), all participants will receive open-label sirolimus to assess long-term efficacy and safety.
Participants will:
1. Phase 1: Take sirolimus (1.5 mg once daily) or a placebo for 24 weeks, plus standardized prednisone (tapered according to protocol) and hydroxychloroquine (0.4 g daily) 2. Phase 2: After completing Phase 1, take open-label sirolimus (1.5 mg once daily) for an additional 24 weeks, continuing stable or tapering doses of prednisone and hydroxychloroquine 3. Visit the clinic at screening, baseline, weeks 4, 12, 24 (end of Phase 1), and then at weeks 28, 36, and 48 (end of Phase 2) for checkups, blood tests, and disease activity assessments 4. Receive telephone follow-ups at weeks 8, 16, 20, 32, 40, and 44 to report platelet counts, medication adherence, and adverse events
Inclusion: Age ≥ 18 and < 65 years; Meet 2012 SLICC or 2019 EULAR/ACR criteria for systemic lupus erythematosus; Meet ITP diagnostic criteria: platelet count ≤ 30×10\^9/L, or ≤ 50×10\^9/L with bleeding tendency; At least two CBC tests showing thrombocytopenia; Bone marrow smear showing megakaryocyte maturation disorder; Willing to sign informed consent form.
Exclusion: Refractory SLE-ITP (no partial response after 3 months of high-dose steroids or immunosuppressants); Contraindications to study drugs; Severe organ involvement (e.g., proteinuria > 1g/24h, CNS involvement, cardiac/GI involvement); Other autoimmune diseases (except Sjögren's syndrome); Malignancy; Active infections (HIV, HBV, HCV, syphilis); Other causes of thrombocytopenia; Use of rituximab within 6 months; Severe liver or kidney dysfunction; Splenomegaly; Pregnancy or breastfeeding; Unhealed major wounds or incisions; Judged unsuitable by investigator.