Tests SHR-1905 injection in people with severe uncontrolled asthma
Tests SHR-1905 injection against a placebo in adults with severe asthma.
Plain-language title generated from the registry record
Registry title: A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
Where in China
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Trial code
- NCT07098403
- Record updated
- 9 September 2025
- Original description
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.Read full original descriptionShow less
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase Ⅲ Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma
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.
Inclusion: Age ≥ 18; Documented physician-diagnosed asthma for at least 12 months; Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months; Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months; At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months; Pre-BD FEV1 < 80% predicted normal; Objective evidence of asthma as documented; Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS; ACQ-6 score ≥ 1.5 at screening and on day of baseline; ePRO adherence ≥ 70% in the 7 days prior to randomization.
Exclusion: participant randomized in the current study or previous SHR-1905 studies; Clinically significant pulmonary disease other than asthma; History of cancer; History of a clinically significant infection; History of chronic alcohol or drug abuse within 12 months; Hepatitis B, C or HIV; History of anaphylaxis following any biologic therapy; Current smokers or participants with smoking history ≥ 10 pack-yrs; Pregnant or breastfeeding.