Systemic Lupus ErythematosusPhase 2/3NCT07657793
Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia
A Phase 2/3 study testing Sirolimus in people with Systemic Lupus Erythematosus and Immune Thrombocytopenia, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Immune Thrombocytopenia
- What is being tested?
- Sirolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2026to 30 Sep 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other causes of thrombocytopenia
- Refractory SLE-ITP (no partial response after 3 months of high-dose steroids or immunosuppressants)
- Use of rituximab within 6 months
- Severe organ involvement (e.g., proteinuria > 1g/24h, CNS involvement, cardiac/GI involvement)
- Other autoimmune diseases (except Sjögren's syndrome)
- Malignancy
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- Active infections (HIV, HBV, HCV, syphilis)
- Severe liver or kidney dysfunction
- Splenomegaly
- Pregnancy or breastfeeding
- Contraindications to study drugs
- Unhealed major wounds or incisions
- Judged unsuitable by investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Liying Peng, liying_peng@qq.com
About this study
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
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:
Read more
- Does sirolimus increase the overall response rate (complete or partial remission of thrombocytopenia) at 24 weeks compared with placebo?
- The safety issues when taking sirolimus over 24 weeks (Phase 1) and up to 48 weeks (Phase 2).
- 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:
- 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)
- 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
- 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
- Receive telephone follow-ups at weeks 8, 16, 20, 32, 40, and 44 to report platelet counts, medication adherence, and adverse events
- Being tested
- Sirolimus, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Sirolimus 1.5mg/day + prednisone + hydroxychloroquine
PlaceboDrug
Placebo + prednisone + hydroxychloroquine
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus | Experimental | Not described Receives: Drug: Sirolimus |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (complete response + partial response) of ITP at Week 24
Complete response: platelet count ≥ 100×10^9/L with no overt bleeding Partial response: platelet count ≥ 30×10^9/L and doubled from baseline, with no overt bleeding
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start7 Jun 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657793
- Sponsor's protocol ID
- SiroinSLEITP
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07657793
- Acronym / sponsor ID
- SiroinSLEITP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 7 Jun 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does sirolimus increase the overall response rate (complete or partial remission of thrombocytopenia) at 24 weeks compared with placebo?
- The safety issues when taking sirolimus over 24 weeks (Phase 1) and up to 48 weeks (Phase 2).
- 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:
- 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)
- 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
- 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
- Receive telephone follow-ups at weeks 8, 16, 20, 32, 40, and 44 to report platelet counts, medication adherence, and adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus | Experimental | Drug: Sirolimus |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Other causes of thrombocytopenia
- Refractory SLE-ITP (no partial response after 3 months of high-dose steroids or immunosuppressants)
- Use of rituximab within 6 months
- Severe organ involvement (e.g., proteinuria > 1g/24h, CNS involvement, cardiac/GI involvement)
- Other autoimmune diseases (except Sjögren's syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SirolimusSirolimus 1.5mg/day + prednisone + hydroxychloroquine | Drug | Sirolimus |
| PlaceboPlacebo + prednisone + hydroxychloroquine | Drug | Placebo |
Primary outcome
Overall response rate (complete response + partial response) of ITP at Week 24
Time frame: Week 24
Complete response: platelet count ≥ 100×10^9/L with no overt bleeding Partial response: platelet count ≥ 30×10^9/L and doubled from baseline, with no overt bleeding
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sirolimus in people with Systemic Lupus Erythematosus and Immune Thrombocytopenia, run by Chinese SLE Treatment And Research Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liying Peng (86 010 69159958, liying_peng@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (complete response + partial response) of ITP at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.