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Recruiting NCT06653322

A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma

Phase III Interventional Asthma With Eosinophilic Phenotype

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HR-1703, Placebo.
Who it may be relevant to
Registry conditions: Asthma With Eosinophilic Phenotype. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Interventions

  • Drug HR-1703
    HR-1703 will be administered by SC injection.
  • Drug Placebo
    Matching Placebo will be administered by the SC injection.

Primary outcome measures

  • Annualised asthma exacerbation rate，about 48weeks [Time frame: about 48weeks]
Secondary outcome measures (12)
  • Mean number of days with oral corticosteroids taken for exacerbation，about 48weeks [Time frame: about 48weeks]
  • Frequency of exacerbations requiring hospitalisation，about 48weeks [Time frame: about 48weeks]
  • Time to first exacerbation requiring hospitalisation，about 48weeks [Time frame: about 48weeks]
  • Mean change from baseline in clinic pre- and post-BD FEV1，about 64 weeks [Time frame: about 64 weeks]
  • Mean change from baseline in clinic pre- and post-BD FEV1%，about 64weeks [Time frame: about 64weeks]
  • Mean change from baseline in clinic pre- and post-BD FVC，about 64 weeks [Time frame: about 64 weeks]
  • Mean change from baseline in clinic pre- and post-BD PEF，about 64 weeks [Time frame: about 64 weeks]
  • Mean change from baseline in FeNO，about 64weeks [Time frame: about 64weeks]
  • Mean change from baseline in asthma control questionnaire (ACQ-6) score，about 64 weeks [Time frame: about 64 weeks]
  • Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score，about 64weeks [Time frame: about 64weeks]
  • Mean change from baseline in Asthma symptom score at week 12/24/36/48/60，about 64weeks [Time frame: at week 12/24/36/48/60，about 64weeks]
  • Mean change from baseline in daily rescue medication use at week 12/24/36/48/60，about 64weeks [Time frame: at week 12/24/36/48/60，about 64weeks]

Eligibility criteria

Inclusion criteria

  • At least 12 years of age
  • A minimum weight of 40kg
  • A medical history of at least 1 year that meets the diagnosis of asthma;
  • Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
  • Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
  • Absolute count of blood eosinophils suggests eosinophilic asthma
  • During the screening period and baseline, pre- BD FEV1% < 80%
  • During the screening period and baseline, ACQ-6 score indicates asthma poor control
  • History of severe asthma exacerbation within the past 12 months prior to screening
  • Good compliance with eDiary completion
  • Take efficient contraceptive measures
  • Voluntarily sign the informed consent form to participate in this study

Exclusion criteria

  • With other condition that could lead to elevated eosinophils
  • With Clinically significant pulmonary diseases
  • With existing immunodeficiency disease
  • With other clinically significant diseases that may affect lung function
  • With uncontrolled severe cardiovascular and cerebrovascular diseases
  • With uncontrolled hypertension and/or diabetes
  • With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
  • Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
  • Existing parasitic infections
  • Diagnosed as malignant tumor within the first 5 years of randomization
  • Significant abnormalities in screening period or baseline laboratory tests
  • Screening period or baseline ECG QTc prolongation
  • Prohibited drugs using during the pre randomization period
  • Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening
  • Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
  • History of drug use, alcoholism, or substance abuse within the past year prior to screening
  • Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
  • Pregnant or lactating subjects
  • Other reasons why the researcher deemed it unsuitable for conducting this experiment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • West China School of Medicine West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT06653322 · SHR-1703-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗