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NCT Number: NCT06323213

Efficacy and Safety Study of 610 in Patients With Severe Asthma

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

610

Drug

610 subcutaneously injection.

Placebo

Drug

Placebo subcutaneously injection.

Primary outcomes

  1. Annualized rate of severe exacerbation events

    Time frame: Up to 52 weeks

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

Secondary outcomes

  1. Time to first severe exacerbation event

    Time frame: Up to 52 weeks

    Time to first severe exacerbation event during the 52-week placebo-controlled treatment period

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

    Time frame: Up to 52 weeks

    Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period

  3. Change from baseline in ACQ score

    Time frame: Up to 52 weeks

    Change from baseline to week 52 in ACQ score

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

    Time frame: Up to 52 weeks

    Change from baseline to week 52 in SGRQ score

  5. Change in pre-bronchodilator forced expiratory volume (FEV1)

    Time frame: Up to 52 weeks

    Absolute change from baseline to week 52 in pre-bronchodilator FEV1

  6. Assessment of adverse events (AEs)

    Time frame: Up to 60 weeks

    Number of participants with adverse events (AEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Qinghong Zhou, MD

CONTACT

[email protected]

+86 18911301578

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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