NCT06653322Active, not recruitingPhase 3
A Multi-centered,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 401 (actual)
- First submitted
- 20 Oct 2024
- Start date
- 21 Nov 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- Asthma
- NCT number
- NCT06653322
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 401
- From 21 Nov 2024 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
- Existing parasitic infections
- Diagnosed as malignant tumor within the first 5 years of randomization
- Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
Lab values
- Significant abnormalities in screening period or baseline laboratory tests
- Screening period or baseline ECG QTc prolongation
Other
- Pregnant or lactating subjects
- Other reasons why the researcher deemed it unsuitable for conducting this experiment
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China School of Medicine/West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.