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

Phase 2Active Not RecruitingNCT06680947

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.225 enrolled

Overview

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

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 weeks and follow-up period of 8 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

225

Conditions

Asthma

Interventions

610DRUG

Subcutaneously injection.

610DRUG

Subcutaneously injection.

PlaceboDRUG

Subcutaneously injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 General Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52

FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.

Time frame: Baseline (Day 1) and at week 52

Secondary Outcomes

Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16

FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.

Time frame: Baseline (Day 1) and at week 16

Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12,16, 20, 28, 36, 44, 52

Percentage of FEV1 will be measured using spirometry.

Time frame: Baseline (Day 1) and at week 4, 8,12,16, 20, 28, 36, 44, 52

Number of asthma exacerbation through study week 52

Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period

Time frame: From baseline (Day 1) to week 52

Number of asthma exacerbations requiring hospitalization or emergency room visits

Asthma exacerbations that are associated with a hospitalization or an emergency room visit.

Time frame: From baseline (Day 1) to week 52

Change from baseline in Asthma Control Questionnaire (ACQ) score.

The ACQ contains five symptom questions (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze), one bronchodilator question and pre-bronchodilator FEV1 level. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ score is the average of the responses. Higher score indicates more limitations.

Data from ClinicalTrials.gov

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