A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
SHR-1905 Injection
DrugSHR-1905 injection.
SHR-1905 Placebo Injection
DrugSHR-1905 placebo Injection.
Treatment groups
408 Participants
are divided into 2 treatment groupsGroup A: SHR-1905 GroupExperimental treatment 1 intervention
Group B: SHR-1905 Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Annual asthma exacerbation rate
Time frame
During 48 weeks of treatment.Secondary outcomes
1
Mean change from baseline in pre-dose/pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)
Time frame
At Week 48.2
Proportion of participants who had asthma exacerbations
Time frame
From randomization to Week 48.3
Time to the first asthma exacerbation
Time frame
From randomization to Week 48.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov