Recruiting
Phase 3
A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia
Condition(s) studied
Primary Immune Thrombocytopenia
Investigational drug(s) / intervention(s)
TQB3473 TabletsTQB3473 Placebo
TQB3473 Tablets: TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
TQB3473 Placebo: Placebo contains no active substance.
Study summary
This is a randomized, double-blind, placebo-controlled Phase III clinical study designed to demonstrate that TQB3473 tablets significantly improve the sustained response rate compared to placebo in adult patients with chronic ITP who have previously received standard corticosteroid therapy and have failed or relapsed after at least one standard ITP treatment.
The study consists of a treatment period and a safety follow-up period.
Eligibility
Inclusion Criteria:
* Subjects voluntarily join this study, sign the informed consent form (ICF), and demonstrate good compliance;
* Male or female subjects aged 18 to 75 years (calculated based on the date of signing the informed consent form);
* Eastern Cooperative Oncology Group (ECOG) score of 0-1;
* Diagnosis of primary ITP prior to randomization, with a duration of ≥12 months;
* An average of at least three independent platelet counts (spaced more than 3 days apart) within the 3 months prior to randomization \<30×10\^9/L, with no count \>35×10\^9/L; and no severe bleeding within 4 weeks prior to screening;
* Previous treatment with glucocorticoids and at least one standard ITP therapy that was ineffective or resulted in relapse.
* Female subjects of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of study treatment, with a negative serum or urine pregnancy test within 7 days prior to study enrollment; male subjects must agree to use effective contraception during the study and for 6 months after the end of study treatment, as detailed in Section 5.5.
Exclusion Criteria:
* Evidence of secondary causes of ITP (e.g., untreated Helicobacter pylori infection, leukemia, lymphoma, history of autoimmune diseases such as systemic lupus erythematosus, Hashimoto's thyroiditis, etc.) or drug-induced causes (e.g., anticonvulsants, antibiotics, heparin, etc.), or immune-mediated cytopenia involving two or more cell lines such as Evans syndrome or immune-related cytopenia;
* Subjects with a history or current diagnosis of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other malignant hematologic diseases;
* History of or concurrent other malignancies within the past 3 years. Exceptions include: other malignancies treated with a single surgical procedure and achieving continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\];
* Conditions affecting venous blood sampling or multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
* Adverse reactions from previous treatments have not resolved to ≤CTCAE grade 1, except for non-clinically significant and asymptomatic laboratory abnormalities judged by the investigator to pose no safety risks;
* Previous bone marrow/hematopoietic stem cell transplantation or major solid organ transplantation;
* Vaccination within 8 weeks prior to randomization or planned vaccination during the study period;
* Major surgical treatment or significant traumatic injury within 4 weeks prior to randomization, or anticipated need for major elective surgery during the study treatment period (major surgery is defined as level 3 or higher according to the National Surgical Classification Catalog 2022);
* History of intracranial hemorrhage or other severe bleeding in vital organs (≥CTCAE grade 3), or symptomatic gastrointestinal bleeding (e.g., hematemesis, melena, etc., excluding asymptomatic "occult blood test positive" and hemorrhoids) within 6 months prior to screening;
* Arterial/venous thrombotic events within 12 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism;
* ITP-related symptoms and treatments:
1. Receipt of immunoglobulins or platelet transfusions within 2 weeks prior to randomization;
2. Receipt of treatments aimed at increasing platelet counts (including but not limited to glucocorticoids, Thyroid peroxidase (TPO), Thrombopoietin receptor agonists (TPO-RAs), cyclosporine, herbal medicines, etc.) within 4 weeks prior to randomization, except for those meeting inclusion criterion (8);
3. Use of rituximab or other anti-cluster of differentiation 20 (CD20) drugs within 14 weeks prior to randomization;
4. Splenectomy within 12 weeks prior to randomization.
* Need for long-term/continuous use of medications affecting platelet function \[including but not limited to aspirin, clopidogrel, ticagrelor, non-steroidal anti-inflammatory drugs (NSAIDs), etc.\] or anticoagulant therapy;
* Known allergy to the active ingredient or excipients of the investigational drug;
* Previous treatment with Syk inhibitors;
* Participation in another clinical trial and use of investigational drugs within 4 weeks prior to randomization;
* Any condition judged by the investigator to pose a significant risk to the subject's safety or to affect the subject's ability to complete the study.
Primary outcome measure(s)
- Durable response rate: platelet counts ≥50×10^9/L — During the 24-week randomized double-blind treatment period (Weeks 14-24)
During the 24-week randomized double-blind treatment period (Weeks 14-24), platelet counts ≥50×10\^9/L in at least 4 out of the 6 protocol-specified visits (excluding rescue treatment).
Trial sites (53)
| Facility | City | Region | Status |
| The first affiliated hospital of ustc anhui provincial hospital |
Hefei |
Anhui |
Not Yet Recruiting |
| The First Affiliated Hospital of Wannan Medical College |
Wuhu |
Anhui |
Not Yet Recruiting |
| Beijing Chaoyang Hospital, Capital Medical University |
Beijing |
Beijing Municipality |
Not Yet Recruiting |
| Peking Union Medical College Hospital |
Beijing |
Beijing Municipality |
Not Yet Recruiting |
| The Second Affiliated Hospital of Chongqing Medical University |
Chongqing |
Chongqing Municipality |
Not Yet Recruiting |
| The First Hospital of Lanzhou University |
Lanzhou |
Gansu |
Not Yet Recruiting |
| Nanfang Hospital, Southern Medical University |
Guangzhou |
Guangdong |
Not Yet Recruiting |
| Shenzhen Nanshan People's Hospital |
Shenzhen |
Guangdong |
Not Yet Recruiting |
| Central People's Hospital of Zhanjiang |
Zhanjiang |
Guangdong |
Not Yet Recruiting |
| The Second Affiliated Hospital of Guangxi Medical University |
Nanning |
Guangxi |
Not Yet Recruiting |
| The Affiliated Hospital of Guizhou Medical University |
Guiyang |
Guizhou |
Not Yet Recruiting |
| The First Affiliated Hospital of Hainan Medical University |
Haikou |
Hainan |
Not Yet Recruiting |
| Affiliated Hospital of Hebei University / School of Clinical Medicine |
Baoding |
Hebei |
Recruiting |
| Affiliated Hospital of ChengDe Medical University |
Chengde |
Hebei |
Not Yet Recruiting |
| The First Hospital of Hebei Medical University |
Shijiazhuang |
Hebei |
Not Yet Recruiting |
| North China University of science and technology |
Tangshan |
Hebei |
Not Yet Recruiting |
| The First Affiliated Hospital of Harbin Medical University |
Harbin |
Heilongjiang |
Not Yet Recruiting |
| Anyang People's Hospital |
Anyang |
Henan |
Not Yet Recruiting |
| Nanyang Central Hospital |
Nanyang |
Henan |
Not Yet Recruiting |
| Xuchang Central Hospital |
Xuchang |
Henan |
Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University |
Zhengzhou |
Henan |
Not Yet Recruiting |
| Henan Cancer Hospital |
Zhengzhou |
Henan |
Not Yet Recruiting |
| The First People's Hospital of Ping Ding Shan |
Zhengzhou |
Henan |
Not Yet Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
Wuhan |
Hubei |
Not Yet Recruiting |
| Zhongnan Hospital of Wuhan University |
Wuhan |
Hubei |
Not Yet Recruiting |
| The Third Hospital of Changsha |
Changsha |
Hunan |
Not Yet Recruiting |
| Nanjing Drum Tower Hospital |
Nanjing |
Jiangsu |
Not Yet Recruiting |
| Jiangsu Province Hospital |
Nanjing |
Jiangsu |
Not Yet Recruiting |
| Affiliated Hospital of Nantong University |
Nantong |
Jiangsu |
Not Yet Recruiting |
| Northern Jiangsu People's Hospital Affiliated to Yangzhou University |
Yangzhou |
Jiangsu |
Not Yet Recruiting |
| Ganzhou People's Hospital |
Ganzhou |
Jiangxi |
Not Yet Recruiting |
| The First Affiliated Hospital of NanChang University |
Nanchang |
Jiangxi |
Not Yet Recruiting |
| The first hospital of Jilin University |
Changchun |
Jilin |
Not Yet Recruiting |
| Shenjing Hospital Of China Medical University |
Shenyang |
Liaoning |
Not Yet Recruiting |
| Qinghai University Affiliated Hospital |
Xining |
Qinghai |
Not Yet Recruiting |
| Xijing Hospital |
Xi'an |
Shaanxi |
Not Yet Recruiting |
| Xi'an No.3 Hospital |
Xi'an |
Shaanxi |
Not Yet Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University |
Xi'an |
Shaanxi |
Not Yet Recruiting |
| Qilu Hospital of Shandong University |
Jinan |
Shandong |
Not Yet Recruiting |
| Shandong First Medical University Affiliated Central Hospital |
Jinan |
Shandong |
Not Yet Recruiting |
+ 13 more sites — see the full list on the official registry below.
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