A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

The purpose of this study is to evaluation the long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients

Eligibility criteria

Qualifiers

At least 18 years of age, Male or Femal.

A minimum weight of 40kg.

Subjects with the clinical features of asthma that meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)" and has a medical history of at least 1 year.

Documentation of current asthma controller medication [medium or high dose ICS and at least one of additional controller such as long-acting muscarinic antagonist (LAMA), long-acting beta2-agonist (LABA) and leukotriene receptor antagonist (LTRA)] for at least 1 stable month before first administration of SHR-1703.

Disqualifiers

Presence of a clinically important lung condition. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis or a history of lung cancer.

A known immunodeficiency.

Presence of a clinically significant and uncontrolled serious cardiovascular and cerebrovascular disease, including but not limited to myocardial infarction, unstable angina, heart failure, stroke, and subarachnoid haemorrhage.

Within the first 4 weeks before visit 0, presence of exacerbation of allergic rhinitis or sinusitis, or a history of infections with clinical significance and/or requiring clinical intervention, including but not limited to respiratory infections.

Trial design

Treatments tested in this trial

  • SHR-1703 Injection

Treatment groups

200 Participants
are divided into 1 treatment group