A Multi-centered,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• At least 12 years of age

• A minimum weight of 40kg

• A medical history of at least 1 year that meets the diagnosis of asthma;

• Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months

• Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month

• Absolute count of blood eosinophils suggests eosinophilic asthma

• During the screening period and baseline, pre- BD FEV1% \< 80%

• During the screening period and baseline, ACQ-6 score indicates asthma poor control

• History of severe asthma exacerbation within the past 12 months prior to screening

⁃ Good compliance with eDiary completion

⁃ Take efficient contraceptive measures

⁃ Voluntarily sign the informed consent form to participate in this study

Locations
Other Locations
China
West China School of Medicine West China Hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Xiaopeng Wang
xiaopeng.wang@hengrui.com
+086-18260387118
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2027-12
Participants
Target number of participants: 400
Treatments
Experimental: Subjects receiving SHR-1703 dose 1
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Guangdong Hengrui Pharmaceutical Co., Ltd

This content was sourced from clinicaltrials.gov