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Active, Not Recruiting

NCT Number: NCT06680947

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

610

Drug

Subcutaneously injection.

Placebo

Drug

Subcutaneously injection.

Primary outcomes

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

    Time frame: Baseline (Day 1) and 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.

Secondary outcomes

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

    Time frame: Baseline (Day 1) and 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.

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

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

    Percentage of FEV1 will be measured using spirometry.

  3. Number of asthma exacerbation through study week 52

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

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

  4. Number of asthma exacerbations requiring hospitalization or emergency room visits

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

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

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

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

    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.

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

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

    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.

  7. Assessment of adverse events (AEs)

    Time frame: Up to week 60

    Number of participants with adverse events (AEs)

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 IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2024
Registry last updated
Jan 29, 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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