Immune Thrombocytopenia (ITP)Phase 2NCT07057778
Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP
A Phase 2 study testing Iguratimod and low-dose rituximab in people with Immune Thrombocytopenia (ITP), run by Peking University People's Hospital at 1 site in China.
Trial summary
Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- What is being tested?
- Iguratimod and low-dose rituximab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ITP confirmed by excluding other supervened causes of thrombocytopenia;
- Platelet count of less than 30×10^9/L at enrollment;
- Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
Who cannot join
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);
- Congestive heart failure;
- Severe arrhythmia;
- Nursing or pregnant women;
- Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria;
- Creatinine or serum bilirubin levels each 1•5 times or more than the normal range;
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- Active or previous malignancy;
- Patients with other diseases were undergoing treatment with immunosuppressants;
- Patients with ITP had received rituximab;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.
Read the detailed description
Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. The small molecule compound iguratimod is widely used as a novel antirheumatic drug to treat several autoimmune diseases. According to studies involving ITP mice, iguratimod may represent a new approach for the prevention and treatment of anti-platelet antibody-mediated ITP by modulating T-cell differentiation.
A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+iguratimod and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment.Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and iguratimod in patients with steroid-resistant/relapsed ITP.
- Conditions
- Immune Thrombocytopenia (ITP)
- Being tested
- Iguratimod, low-dose rituximab
- Keywords
- Iguratimod
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
oral iguratimod at 25mg twice daily for 26 weeks
low-dose rituximabDrug
rituximab 100mg once weekly for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod plus low-dose rituximab | Experimental | Low-dose rituximab was used in combination with Iguratimod Receives: Drug: Iguratimod; Drug: low-dose rituximab |
| Low-dose rituximab | Active comparator | Low-dose rituximab alone Receives: Drug: low-dose rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response
The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count >=100x10^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.
Measured: From the start of study treatment (Day 1) up to the end of Year 1
Secondary outcomes (7)
sustained response
The number of participants that can maintain the platelet count > 30 x 109/L, an absence of bleeding events, and without requirement for any other ITP-specific treatment for 6 consecutive months after achievement of response.
Measured: From the start of study treatment (Day 1) up to the end of Year 1
complete response
The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.
Measured: From the start of study treatment (Day 1) up to the end of Year 1
time to response
Time to response was defined as the time from starting treatment to the time to achieve the response.
Measured: From the start of study treatment (Day 1) up to the end of Year 1
duration of response
Duration of response was measured from the achievement of response to the loss of response.
Measured: From the start of study treatment (Day 1) up to the end of Year 1
incidence of adverse events
From the start of study treatment (Day 1) up to the end of Year 1
Measured: All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to CTCAE 5.0
Bleeding events
Clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale.
Measured: From the start of study treatment (Day 1) up to the end of Year 1
Health-related quality of life (HRQoL)
ITP-PAQ is used to assess the Health Related Quality of Life (HRQoL) before and after treatment.
Measured: From the start of study treatment (Day 1) up to the end of Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned at a 1:1 ratio to receive Iguratimod plus low-dose rituximab or high-dose rituximab alone. Each group requires 60 patients.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Beijing Friendship Hospital, Navy General Hospital, Beijing, Beijing Tongren Hospital
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiaohui Zhang, Principal investigator, Peking University Institute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057778
- Sponsor's protocol ID
- Pku-IGU-ITP-03
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP
- ClinicalTrials.gov ID
- NCT07057778
- Acronym / sponsor ID
- Pku-IGU-ITP-03
- Conditions
- Immune Thrombocytopenia (ITP)
- Keywords
- Iguratimod
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Beijing Friendship Hospital, Navy General Hospital, Beijing, Beijing Tongren Hospital
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Jul 2025 (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.
Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.
Detailed description
Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. The small molecule compound iguratimod is widely used as a novel antirheumatic drug to treat several autoimmune diseases. According to studies involving ITP mice, iguratimod may represent a new approach for the prevention and treatment of anti-platelet antibody-mediated ITP by modulating T-cell differentiation.
A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+iguratimod and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment.Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and iguratimod in patients with steroid-resistant/relapsed ITP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomly assigned at a 1:1 ratio to receive Iguratimod plus low-dose rituximab or high-dose rituximab alone. Each group requires 60 patients.
| Arm | Type | Receives |
|---|---|---|
| Iguratimod plus low-dose rituximab | Experimental | Drug: Iguratimod, Drug: low-dose rituximabLow-dose rituximab was used in combination with Iguratimod |
| Low-dose rituximab | Active comparator | Drug: low-dose rituximabLow-dose rituximab alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ITP confirmed by excluding other supervened causes of thrombocytopenia;
- Platelet count of less than 30×10^9/L at enrollment;
- Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
Key exclusion criteria (9 listed)
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);
- Congestive heart failure;
- Severe arrhythmia;
- Nursing or pregnant women;
- Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria;
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 |
|---|---|---|
| Iguratimodoral iguratimod at 25mg twice daily for 26 weeks | Drug | Iguratimod plus low-dose rituximab |
| low-dose rituximabrituximab 100mg once weekly for 6 weeks | Drug | Iguratimod plus low-dose rituximab, Low-dose rituximab |
Primary outcome
overall response
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count >=100x10^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.
7 secondary outcomes
sustained response
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
complete response
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
time to response
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
duration of response
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
incidence of adverse events
Time frame: All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to CTCAE 5.0
Bleeding events
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
Health-related quality of life (HRQoL)
Time frame: From the start of study treatment (Day 1) up to the end of Year 1
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 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Xiaohui Zhang principal investigator
Peking University Institute of Hematology, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iguratimod and low-dose rituximab in people with Immune Thrombocytopenia (ITP), run by Peking University People's Hospital 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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 10 Jul 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Xiaohui Zhang (+8613522338836, zhangxh@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response (time frame: From the start of study treatment (Day 1) up to the end of Year 1). 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 10 Jul 2025.