RecruitingPhase 3NCT07098403
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
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
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Enrollment
408 participants
Start Date
Sep 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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 Criteria9
- 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.
Interventions
DRUGSHR-1905 Injection
SHR-1905 injection.
DRUGSHR-1905 Placebo Injection
SHR-1905 placebo Injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07098403
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