Efficacy and Safety Study of 610 in Patients With Severe Asthma

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma

The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: 610; Drug: Placebo

Detailed Description

The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qinghong Zhou, MD; Phone Number: +86 18911301578; Email: zhouqinghong@3sbio.com

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Able to give written informed consent prior to participation in the study.
2. Male or female adults ages 18 to 75 years old when signing the informed consent.
3. Documented diagnosis of asthma for at least one year prior to screening.
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.

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

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of severe exacerbation events	Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first severe exacerbation event	Time to first severe exacerbation event during the 52-week placebo-controlled treatment period	Up to 52 weeks
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit	Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period	Up to 52 weeks
Change from baseline in ACQ score	Change from baseline to week 52 in ACQ score	Up to 52 weeks
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)	Change from baseline to week 52 in SGRQ score	Up to 52 weeks
Change in pre-bronchodilator forced expiratory volume (FEV1)	Absolute change from baseline to week 52 in pre-bronchodilator FEV1	Up to 52 weeks
Assessment of adverse events (AEs)	Number of participants with adverse events (AEs)	Up to 60 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 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-III-01

Drug and device information, study documents

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