NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma

Active Not RecruitingPhase 2

Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Conditions: Asthma

Interventions: 610, 610, Placebo

Countries: China

This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 1\. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
* 2\. Female and male aged 18 to 75 years.
* 3\. Diagnosed with asthma for ≥12 months that meet GINA.
* 4\. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
* 5\. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
* 6\. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.

Exclusion Criteria:

* 1\. Presence of a known pre-existing, clinically important lung condition other than Asthma.
* 2\. Severe asthma exacerbation within 4 weeks prior to randomization.
* 3\. Subjects with any eosinophilic diseases other than asthma.
* 4\. Known, pre-existing severe or clinically significant cardiovascular disease.
* 5\. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
* 6\. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
* 7\. Subjects with allergy/intolerance to a monoclonal antibody.

Locations (1)

Shanghai, Shanghai Municipality, China