Evaluating TQC2731 Injection Versus Placebo for Adults with Poorly Controlled Severe Asthma A Randomized, Double-Blind, Placebo-Controlled Phase III Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III clinical trial where 660 participants with asthma are randomly assigned to receive either TQC2731 or a placebo. The study aims to see if TQC2731 can reduce asthma worsening episodes over one year compared to placebo. Participants receive either the TQC2731 injection or placebo every four weeks for up to 48 weeks through subcutaneous injection. The treatment cycles repeat monthly from the start until Week 48. The study compares these two groups to assess the impact on asthma symptoms and lung function. Throughout the trial, participants will have regular assessments including lung function tests, asthma symptom diaries, quality of life questionnaires, and blood tests for inflammation markers and immune response. Researchers track the number of asthma exacerbations during the 52 weeks of treatment and up to 64 weeks for some outcomes. Safety and immune reactions are monitored carefully. The total study duration for each participant is about one year of treatment plus follow-up.

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection