NCT06900920

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	TQB3473 Tablets	TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
DRUG	TQB3473 Placebo	Placebo contains no active substance.

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2025-03-28
• Last updated: 2025-05-20

Locations

53 sites across 1 country: China