A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia (ITP)
1 other identifier
interventional
199
1 country
53
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2025
Typical duration for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 28, 2025
CompletedStudy Start
First participant enrolled
April 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 20, 2025
November 1, 2024
1.8 years
March 24, 2025
May 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Durable response rate: platelet counts ≥50×10^9/L
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).
During the 24-week randomized double-blind treatment period (Weeks 14-24)
Secondary Outcomes (8)
The effectiveness rate within the first 12 weeks of treatment
Baseline to 12 weeks
The response rate within 24 weeks of treatment
24 weeks
Time to response: The time from the initiation of treatment to the first platelet count ≥50×10^9/L
The time from the initiation of treatment to the first platelet count ≥50×10^9/L (excluding rescue treatment)
The incidence and severity of bleeding events (Weeks 1-12)
During Weeks 1-12 of the double-blind treatment period
The incidence and severity of bleeding events (Weeks 1-24)
During Weeks 1-24 of the double-blind treatment period
- +3 more secondary outcomes
Study Arms (2)
TQB3473 Tablets
ACTIVE COMPARATORTQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks.
TQB3473 Placebo
PLACEBO COMPARATORPlacebo, orally once daily for 24 consecutive weeks.
Interventions
TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- Receipt of immunoglobulins or platelet transfusions within 2 weeks prior to randomization;
- Use of rituximab or other anti-cluster of differentiation 20 (CD20) drugs within 14 weeks prior to randomization;
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
The first affiliated hospital of ustc anhui provincial hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Shenzhen Nanshan People's Hospital
Shenzhen, Guangdong, 518000, China
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, 524045, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530005, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
Affiliated Hospital of Hebei University / School of Clinical Medicine
Baoding, Hebei, 071000, China
Affiliated Hospital of ChengDe Medical University
Chengde, Hebei, 067000, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050023, China
North China University of science and technology
Tangshan, Hebei, 063000, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Anyang People's Hospital
Anyang, Henan, 455112, China
Nanyang Central Hospital
Nanyang, Henan, 473001, China
Xuchang Central Hospital
Xuchang, Henan, 461000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First People's Hospital of Ping Ding Shan
Zhengzhou, Henan, 450003, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
The Third Hospital of Changsha
Changsha, Hunan, 410035, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226006, China
Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Yangzhou, Jiangsu, 225009, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341001, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006, China
The first hospital of Jilin University
Changchun, Jilin, 130400, China
Shenjing Hospital Of China Medical University
Shenyang, Liaoning, 110000, China
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000, China
Xijing Hospital
Xi'an, Shaanxi, 710000, China
Xi'an No.3 Hospital
Xi'an, Shaanxi, 710018, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Shandong First Medical University Affiliated Central Hospital
Jinan, Shandong, 250013, China
Linyi Central Hospital
Linyi, Shandong, 276401, China
Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University)
Yantai, Shandong, 264099, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200030, China
Affiliated Zhongshan Hospital of Fudan University，Qingpu Branch
Shanghai, Shanghai Municipality, 201700, China
Heping Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300070, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000830000, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Kunming Medical University Second Affiliated Hospital
Kunming, Yunnan, 650033, China
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2025
First Posted
March 28, 2025
Study Start
April 30, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 20, 2025
Record last verified: 2024-11