Efficacy and Safety Study of 610 in Patients With Severe Asthma

NCT06323213 | Recruiting Phase 3

• 1 other identifier: SSGJ-610-BA-III-01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to first severe exacerbation event

  Up to 52 weeks

• Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit

  Up to 52 weeks

• Change from baseline in ACQ score

  Up to 52 weeks

• Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)

  Up to 52 weeks

• Change in pre-bronchodilator forced expiratory volume (FEV1)

  Up to 52 weeks

Study Arms (2)

610 group

EXPERIMENTAL

Subjects will receive 610 for 52 weeks.

Drug: 610

placebo group

PLACEBO COMPARATOR

Subjects will receive placebo for 52 weeks.

Drug: Placebo

Interventions

610 DRUG

610 subcutaneously injection.

610 group

Placebo DRUG

Placebo subcutaneously injection.

placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written informed consent prior to participation in the study.
• Male or female adults ages 18 to 75 years old when signing the informed consent.
• Documented diagnosis of asthma for at least one year prior to screening.
• History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.

You may not qualify if:

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

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghong Zhou, MD

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CN (1)