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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HR-1703

    Drug

    HR-1703 will be administered by SC injection.

  • Placebo

    Drug

    Matching Placebo will be administered by the SC injection.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Subjects receiving SHR-1703 dose 1Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Annualised asthma exacerbation rate,about 48weeks

Time frame
about 48weeks

Secondary outcomes

1

Mean number of days with oral corticosteroids taken for exacerbation,about 48weeks

Time frame
about 48weeks
2

Frequency of exacerbations requiring hospitalisation,about 48weeks

Time frame
about 48weeks
3

Time to first exacerbation requiring hospitalisation,about 48weeks

Time frame
about 48weeks
4

Mean change from baseline in clinic pre- and post-BD FEV1,about 64 weeks

Time frame
about 64 weeks

Other outcomes

Sponsors and contacts

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