BridgeMD
Tests treatment safety and results for Asthma With Eosinophilic Phenotype
Official title A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
ClinicalTrials.gov ID: NCT06653322
What this study is testing
What is HR-1703?
HR-1703 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for asthma with eosinophilic phenotype.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 people
- Other reasons why the researcher deemed it unsuitable for conducting this experiment
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.