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Tests treatment safety and results for Eosinophilic Asthma Patients
Official title A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients
ClinicalTrials.gov ID: NCT06441812
What this study is testing
What is SHR-1703 Injection?
SHR-1703 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for eosinophilic asthma patients.
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 evaluation the long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age, Male or Femal.
- A minimum weight of 40kg.
- people with the clinical features of asthma that meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Bronchial...
- Documentation of current asthma controller medication [medium or high dose ICS and at least one of additional controller such as long-acting...
- At least one confirmed history of exacerbation within one year of initial administration of SHR-1703, occurring during the use of medium and high...
You likely can't join if
- Presence of a clinically important lung condition. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis or a...
- A known immunodeficiency.
- Presence of a clinically significant and uncontrolled serious cardiovascular and cerebrovascular disease, including but not limited to myocardial...
- Within the first 4 weeks before visit 0, presence of exacerbation of allergic rhinitis or sinusitis, or a history of infections with clinical...
- A known parasitic infection within the first 6 months before visit 0.
- A malignancy history within the first 5 years before visit 0 (people that had localized basal carcinoma of the skin or cervical carcinoma in situ...
See the full eligibility criteria
- At least 18 years of age, Male or Femal.
- A minimum weight of 40kg.
- people 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...
- At least one confirmed history of exacerbation within one year of initial administration of SHR-1703, occurring during the use of medium and high daily dose ICS.
- Absolute count of eosinophils must be ≥0.15×109/L at visit 0 and visit 1.
- A pre-bronchodilator FEV1 \<85% and ≥30% predicted at visit 0 and visit 1.
- Female people with fertility agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures from signing the informed consent form to 14 months after the last dose of SHR-1703, and male...
- people must be able to give written informed consent prior to participation in the study.
- 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...
- 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...
- A known parasitic infection within the first 6 months before visit 0.
- A malignancy history within the first 5 years before visit 0 (people that had localized basal carcinoma of the skin or cervical carcinoma in situ which was resected for cure will not be excluded).
- Blood donation or significant blood loss (≥ 400ml) within the first 4 weeks before visit 0, or infusion of blood products or immunoglobulins.
- Use systemic immunosuppressants (excluding systemic glucocorticoids used for asthma treatment and for non asthma treatment for less than 3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, including...
- people who have previously participated in any study and received Investigational Product within the first 30 days before visit 0.
- There was a surgical plan or other treatment measures that the researcher believed may affect the subject's evaluation during the study period.
- Laboratory examination shows obvious abnormalities at visit 0 and visit 1:
- White blood cell count (WBC) \<3.0×109/L;
- Hemoglobin≤90g/L；
- Platelet\<100×109/L；
- Alanine aminotransferase (ALT)\>2×ULN (upper limit of normal);
- Aspartate aminotransferase (AST) \>2×ULN；
- Total bilirubin (TBIL)\>1.5×ULN;
- Prothrombin time (PT) \>ULN+3s；
- Creatinin\>1.5×ULN;
- Active hepatitis B (positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood), or positive for hepatitis C virus antibody, or positive for human immunodeficiency virus (HIV) antibody, or...
- ECG QTc\>450ms or other clinically significant abnormal results that may pose significant safety risks to the people at visit 0 or visit 1；
- A history of drug addicts or substance abuse within 1 years prior to Visit 0；
- people who are pregnant (positive HCG test at visit 0 or visit 1) or breastfeeding should not be enrolled if they plan to become pregnant during the time of study participation；
- people with a known allergy or intolerance to anti IL-5 monoclonal antibody or other biologic；
- Other reasons determined by the researcher as unsuitable for participation in the study.
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, 18 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.