Actively Recruiting
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-09-09
408
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase III study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.
CONDITIONS
Official Title
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Physician-diagnosed asthma for at least 12 months
- Use of medium or high dose inhaled corticosteroids for at least 3 months
- Use of at least one additional maintenance asthma controller medication for at least 3 months
- Pre-bronchodilator FEV1 less than 80% of predicted normal
- Objective evidence of asthma
- History of at least 2 asthma exacerbations in the past 12 months, with at least one during treatment with medium-to-high dose ICS
- ACQ-6 score of 1.5 or higher at screening and baseline
- Electronic patient-reported outcome adherence of 70% or higher in the 7 days before randomization
You will not qualify if you...
- Clinically significant lung diseases other than asthma
- History of cancer
- History of clinically significant infections
- Current smokers or those with a smoking history of 10 or more pack-years
- History of chronic alcohol or drug abuse within the past 12 months
- Infection with hepatitis B, hepatitis C, or HIV
- Pregnant or breastfeeding women
- History of anaphylaxis after any biologic therapy
- Participation in this or previous SHR-1905 studies
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510830
Actively Recruiting
Research Team
Z
Zhou Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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