The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)

NCT07065968 | Recruiting Phase 2 DMC

• 1 other identifier: TY2025006
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Immune Thrombocytopenia (ITP)

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 24

Secondary Outcomes (6)

• Initial response

  Week 4

• Time to response

  Week 24

• Duration of response

  Week 24

• Bleeding events

  Week 24

• Adverse events

  Week 24

Study Arms (2)

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.

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.

Drug: Dexamethasone

Interventions

Teriflunomide DRUG

Teriflunomide 14 mg orally once daily for 24 weeks.

Teriflunomide plus Dexamethasone

Dexamethasone DRUG

Dexamethasone 40 mg orally once daily for four consecutive days.

Dexamethasone; Teriflunomide plus Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University Health Science Center: collaborator
• Cisen Pharmaceutical CO., LTD.: collaborator

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

teriflunomide; Dexamethasone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Xiao-Hui Zhang, MD

  Peking University Institute of Hematology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Hui Zhang, MD

CONTACT

+8613522338836; zhangxh@bjmu.edu.cn

Li-Ping Yang, MD

CONTACT

+8618519172033; lpyang@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)