SIM0718 Treatment of Asthma Clinical Study
ConditionAsthma; Eosinophilic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-75
SponsorSimcere Pharmaceutical Co., Ltd
About this trial
Phase III clinical study of SIM0718 asthma
Eligibility criteria
Qualifiers
Age 12 to 75 years, weight ≥ 40 kg, diagnosed with asthma for at least 12 months；
Currently receiving medium- to high-dose inhaled corticosteroids (ICS) in combination with 1 or 2 control medications and have been on a stable dose for at least 28 days prior to randomization；
Pre-bronchodilator (trough) FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents ；
Positive bronchodilator response within 12 months prior to randomization or during the screening period;
Disqualifiers
Current respiratory disease that may impair lung function as judged by the investigator;
Diagnosis of helminth parasitic infection within 24 weeks prior to randomization and who have not received or have not responded to standard therapy;
Within 28 days prior to randomization, with acute or chronic infection; or have a severe viral infection;
Has a known or suspected history of immunosuppression or frequent, recurrent, or long-term infection;
Trial design
Treatments tested in this trial
- SIM0718 injection
- SIM0718 injection of placebo
Treatment groups
418 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov