Immune Thrombocytopenia (ITP)Phase 2NCT07065968
The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
A Phase 2 study testing Teriflunomide and Dexamethasone in people with Immune Thrombocytopenia (ITP), run by Peking University People's Hospital at 3 sites in China.
Trial summary
A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- What is being tested?
- Teriflunomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesChina
- Study dates
- 19 Aug 2025to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years;
- Newly diagnosed, treatment naïve ITP patients;
- Patients with a platelet count <30 x10^9/L or a platelet count <50 x10^9/L with bleeding manifestations at the enrollment;
- Willing and able to sign written informed consent.
Who cannot join
- Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);
- Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN);
- Severe cardiac, renal, hepatic, or respiratory insufficiency;
- Severe immunodeficiency;
- Pregnancy or lactation;
- Active or a history of malignancy;
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- Active infection requiring systemic therapy;
- Myelodysplastic syndrome, aplastic anemia, or myelofibrosis;
- A known diagnosis of other autoimmune diseases;
- Patients who are deemed unsuitable for the study by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yu-Jun Dong, MD, +8618210264969, dongy@hsc.pku.edu.cn
- Recruiting
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiao-Hui Zhang, MD, +8613522338836, zhangxh@bjmu.edu.cn
Li-Ping Yang, MD, +8618519172033, lpyang@bjmu.edu.cn
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hong-Mei Jing, MD, +8615611908428, hongmeijing@bjmu.edu.cn
About this study
Official title: Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial
A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
Read the detailed description
The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
- Conditions
- Immune Thrombocytopenia (ITP)
- Being tested
- Teriflunomide, Dexamethasone
- 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.
TeriflunomideDrug
Teriflunomide 14 mg orally once daily for 24 weeks.
DexamethasoneDrug
Dexamethasone 40 mg orally once daily for four consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Teriflunomide plus Dexamethasone | Experimental | Oral Teriflunomide was given at a dose of 14 mg once daily for 24 weeks, and dexamethasone was given at a dose of 40mg orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment. Receives: Drug: Teriflunomide; Drug: Dexamethasone |
| Dexamethasone | Active comparator | Dexamethasone was given at a dose of 40mg, orally once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained response
Sustained response was defined as a platelet count ≥ 30 x10^9/L and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least three of the four visits of the last 8 weeks of treatment.
Measured: Week 24
Secondary outcomes (6)
Initial response
The number of participants with achievement of CR or R at 4 weeks. Complete response (CR) was defined as a platelet count ≥ 100 x10^9/L and absence of bleeding. Response (R) was defined as a platelet count ≥ 30 x10^9/L and at least a 2-fold increase of the baseline count and absence of bleeding. No response was defined as a platelet count of less than 30 x10^9/L, or less than two times increase from baseline platelet count, or bleeding.
Measured: Week 4
Time to response
The time from treatment initiation to time of achievement of CR or R.
Measured: Week 24
Duration of response
The time from the achievement of a CR or R to the loss of CR or R.
Measured: Week 24
Bleeding events
Clinically significant bleeding was assessed using the World Health Organization (WHO) bleeding scale.
Measured: Week 24
Adverse events
Adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: Week 24
Health-related quality of life (HRQoL)
ITP-patient assessment questionnaire (ITP-PAQ) was used to assess the HRQoL before and after treatment.
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 posted15 Jul 2025
- Study start19 Aug 2025
- Primary completion10 Sep 2027 (estimated)
- Study completion30 Dec 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
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Health Science Center, Cisen Pharmaceutical CO., LTD.
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiao-Hui Zhang, MD, Principal investigator, Peking University Institute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065968
- Sponsor's protocol ID
- TY2025006
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2025
- Last updated
- 8 Sep 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial
- ClinicalTrials.gov ID
- NCT07065968
- Acronym / sponsor ID
- TY2025006
- Conditions
- Immune Thrombocytopenia (ITP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University Health Science Center, Cisen Pharmaceutical CO., LTD.
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 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.
A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
Detailed description
The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriflunomide plus Dexamethasone | Experimental | Drug: Teriflunomide, Drug: DexamethasoneOral Teriflunomide was given at a dose of 14 mg once daily for 24 weeks, and dexamethasone was given at a dose of 40mg orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment. |
| Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone was given at a dose of 40mg, orally once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years;
- Newly diagnosed, treatment naïve ITP patients;
- Patients with a platelet count <30 x10^9/L or a platelet count <50 x10^9/L with bleeding manifestations at the enrollment;
- Willing and able to sign written informed consent.
Key exclusion criteria (10 listed)
- Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);
- Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN);
- Severe cardiac, renal, hepatic, or respiratory insufficiency;
- Severe immunodeficiency;
- Pregnancy or lactation;
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 |
|---|---|---|
| TeriflunomideTeriflunomide 14 mg orally once daily for 24 weeks. | Drug | Teriflunomide plus Dexamethasone |
| DexamethasoneDexamethasone 40 mg orally once daily for four consecutive days. | Drug | Dexamethasone, Teriflunomide plus Dexamethasone |
Primary outcome
Sustained response
Time frame: Week 24
Sustained response was defined as a platelet count ≥ 30 x10^9/L and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least three of the four visits of the last 8 weeks of treatment.
6 secondary outcomes
Initial response
Time frame: Week 4
Time to response
Time frame: Week 24
Duration of response
Time frame: Week 24
Bleeding events
Time frame: Week 24
Adverse events
Time frame: Week 24
Health-related quality of life (HRQoL)
Time frame: Week 24
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 8 Sep 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.
Xiao-Hui Zhang, MD principal investigator
Peking University Institute of Hematology, Peking University People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teriflunomide and Dexamethasone in people with Immune Thrombocytopenia (ITP), run by Peking University People's Hospital at 3 sites 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 4 inclusion and 10 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Xiao-Hui Zhang, MD (+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?
Sustained response (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 8 Sep 2025.