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
Qualifiers
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
Treatments tested in this trial
- SHR-1905 Injection
- SHR-1905 Placebo Injection
Treatment groups
408 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov