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Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.

Severe Asthma Clinical Trial

Official title:
A Multicenter,Randomized,Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Poorly Controlled Severe Asthma

Clinical Trial Summary

This is a phase II, multicenter, double-blind, randomized, parallel group, placebo-controlled clinical study to evaluate the effect of three doses of TQC2731 on Annualized Asthma Exacerbation Rates(AAER) in adult subjects with poor control of severe asthma. It is estimated that 220 subjects will be included. The subjects will receive TQC2731 (70 mg Q4w, 210 mg Q4w, 420 mg Q4w) or placebo (Q4w) administered by Subcutaneous (SC) in the ratio of 1:1:1:1. The study comprised a 5 to 6-week screening period, a 52-week treatment period and a 12-week follow-up period. During the treatment period, the study drug will be administered from day 0 until week 48. The study drug was not administered at the 52nd week.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05472324
Study type Interventional
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Jinping Zheng, Doctor
Phone 18928868238
Email jpzhenggy@163.com
Status Recruiting
Phase Phase 2
Start date September 23, 2022
Completion date October 2024
View Details
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