TQB3473 tablets for treating 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)

This study is testing if TQB3473 tablets can help adults with chronic immune thrombocytopenia who haven't responded well to standard treatments feel better and have more stable blood platelet levels.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 199 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Drugs / interventions: rituximab
• Locations: 53 sites (Hefei, Anhui and 52 other locations)
• Trial ID: NCT06900920 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled Phase III study aimed at evaluating the efficacy of TQB3473 tablets in improving the sustained response rate in adults with chronic primary immune thrombocytopenia (ITP) who have previously failed standard corticosteroid therapy. Participants will be monitored during a treatment period followed by a safety follow-up period. The study specifically targets patients who have had a diagnosis of ITP for at least 12 months and have experienced inadequate responses to prior treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with chronic primary ITP who have previously failed standard treatments.

Not a fit: Patients with severe bleeding or those who have not been diagnosed with primary ITP may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with chronic ITP who have not responded to existing therapies.

How similar studies have performed: Other studies have shown promise in treating ITP with novel therapies, but this specific approach with TQB3473 is relatively novel.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 52 other locations

• The first affiliated hospital of ustc anhui provincial hospital — Hefei, Anhui, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (NOT_YET_RECRUITING)
• Beijing Chaoyang Hospital, Capital Medical University — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (NOT_YET_RECRUITING)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Shenzhen Nanshan People's Hospital — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• Central People's Hospital of Zhanjiang — Zhanjiang, Guangdong, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Hebei University / School of Clinical Medicine — Baoding, Hebei, China (RECRUITING)
• Affiliated Hospital of ChengDe Medical University — Chengde, Hebei, China (NOT_YET_RECRUITING)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (NOT_YET_RECRUITING)
• North China University of science and technology — Tangshan, Hebei, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Anyang People's Hospital — Anyang, Henan, China (NOT_YET_RECRUITING)
• Nanyang Central Hospital — Nanyang, Henan, China (NOT_YET_RECRUITING)
• Xuchang Central Hospital — Xuchang, Henan, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• The First People's Hospital of Ping Ding Shan — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• The Third Hospital of Changsha — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (NOT_YET_RECRUITING)
• Northern Jiangsu People's Hospital Affiliated to Yangzhou University — Yangzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of NanChang University — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• The first hospital of Jilin University — Changchun, Jilin, China (NOT_YET_RECRUITING)
• Shenjing Hospital Of China Medical University — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• Qinghai University Affiliated Hospital — Xining, Qinghai, China (NOT_YET_RECRUITING)
• Xijing Hospital — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• Xi'an No.3 Hospital — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Shandong First Medical University Affiliated Central Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Linyi Central Hospital — Linyi, Shandong, China (NOT_YET_RECRUITING)
• Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University) — Yantai, Shandong, China (NOT_YET_RECRUITING)
• Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Affiliated Zhongshan Hospital of Fudan University，Qingpu Branch — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Heping Hospital affiliated to Changzhi Medical College — Changzhi, Shanxi, China (NOT_YET_RECRUITING)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)
• Tianjin People's Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)
• People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Hu Zhou, Doctor

Conditions: Primary Immune Thrombocytopenia