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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma

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

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: 610; Drug: Placebo

Detailed Description

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
• Enrollment (Estimated): 225
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Subjects will receive 610 for 52 weeks.	Drug: 610; Subcutaneously injection.
Experimental: Group B; Subjects will receive 610 for 52 weeks.	Drug: 610; Subcutaneously injection.
Placebo Comparator: Placebo group; Subjects will receive placebo for 52 weeks.	Drug: Placebo; Subcutaneously injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 1) and at week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	From baseline (Day 1) to week 52
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)	The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best.	From baseline (Day 1) to week 52
Assessment of adverse events (AEs)	Number of participants with adverse events (AEs)	Up to week 60

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Investigators: Principal Investigator: Min Zhang, Doctor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: SSGJ-610-BA-II-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No