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.
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;
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.);
Parallel
TQB3473 Tablets
DrugTQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
TQB3473 Placebo
DrugPlacebo contains no active substance.
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).
The effectiveness rate within the first 12 weeks of treatment
①The proportion of subjects with at least one platelet count ≥50×10\^9/L during weeks 1-12 (excluding emergency treatment).②Among subjects with a baseline platelet count \<15×10\^9/L, the proportion of subjects with at least one platelet count ≥30×10\^9/L and an increase of ≥20×10\^9/L from baseline during weeks 1-12 (excluding rescue treatment).
The response rate within 24 weeks of treatment
① The proportion of subjects with at least one platelet count ≥50×10\^9/L during weeks 1-24 (excluding rescue treatment). ② Among subjects with a baseline platelet count \<15×10\^9/L, the proportion of subjects with at least one platelet count ≥30×10\^9/L and an increase of ≥20×10\^9/L from baseline during weeks 1-24 (excluding rescue treatment). ③ The proportion of subjects with platelet counts at least twice the baseline level and ≥30×10\^9/L for at least two consecutive measurements during weeks 1-24 (excluding rescue treatment).
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
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 as assessed by the World Health Organization (WHO) bleeding score.
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