A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (NCT05593250) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
China260 participantsStarted 2023-01-17
Plain-language summary
This study is a phase 2 study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female aged between 18 and 75 years (inclusive)
. Weight ≥ 40 kg
. Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
. Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization
. At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
. At least 2 exacerbations within 12 months before screening
. No birth plan and must agree to take effective contraceptive methods
. Sign informed consent form voluntarily for the trial
Exclusion criteria
. Any clinically important pulmonary disease
. Any disease other than asthma that may affect lung function
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial testing SHR-1905, which means it's still in relatively early testing — what do we know so far about how safe it is and whether it's showing any signs of working for people with severe uncontrolled asthma like mine?
2The trial is no longer enrolling new participants — does that change whether it's worth following, and could my doctor get access to SHR-1905 through any other pathway if the results look promising?
3The main thing this trial is measuring is how often asthma attacks happen each year — given how frequently I'm currently having flare-ups, is reducing that rate the most important goal for my situation, or are there other outcomes I should also be prioritizing?
4Before considering an experimental treatment like SHR-1905, are there approved biologics or other standard therapies for severe uncontrolled asthma that I haven't tried yet that might be a better first step?
5Since this is a Phase 2 study, the full safety profile isn't completely established yet — what side effects or risks have been reported so far, and how do they compare to the risks of my asthma staying uncontrolled?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.