A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1905 Injection, SHR-1905 Placebo Injection.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug SHR-1905 Injection
SHR-1905 injection. - Drug SHR-1905 Placebo Injection
SHR-1905 placebo Injection.
Primary outcome measures
- Annual asthma exacerbation rate [Time frame: During 48 weeks of treatment.]
Secondary outcome measures (3)
- Mean change from baseline in pre-dose/pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1) [Time frame: At Week 48.]
- Proportion of participants who had asthma exacerbations [Time frame: From randomization to Week 48.]
- Time to the first asthma exacerbation [Time frame: From randomization to Week 48.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Clinically significant pulmonary disease other than asthma.
- History of cancer.
- History of a clinically significant infection.
- Current smokers or participants with smoking history ≥ 10 pack-yrs.
- History of chronic alcohol or drug abuse within 12 months.
- Hepatitis B, C or HIV.
- Pregnant or breastfeeding.
- History of anaphylaxis following any biologic therapy.
- participant randomized in the current study or previous SHR-1905 studies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT07098403 · SHR-1905-302