Efficacy and Safety Study of 610 in Patients With Severe Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
About this trial
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
Eligibility criteria
Qualifiers
Able to give written informed consent prior to participation in the study.
Male or female adults ages 18 to 75 years old when signing the informed consent.
Documented diagnosis of asthma for at least one year prior to screening.
History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
Disqualifiers
Presence of a known pre-existing, clinically important lung condition other than asthma.
Severe asthma exacerbation within 4 weeks prior to randomization.
Subjects with any eosinophilic diseases other than asthma.
Known, pre-existing severe or clinically significant cardiovascular disease.
Trial design
Treatments tested in this trial
- 610
- Placebo
Treatment groups
480 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov