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New treatment option for Asthma
Official title A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
ClinicalTrials.gov ID: NCT07098403
What this study is testing
What is SHR-1905 Injection?
SHR-1905 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for asthma.
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
- This study is a phase III 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Age ≥ 18.
- Documented physician-diagnosed asthma for at least 12 months.
- Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.
- Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial...
- At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at...
You likely can't join if
- Clinically significant pulmonary disease other than asthma.
- History of cancer.
- History of a clinically significant infection.
- Current smokers or participants with smoking history ≥ 10 pack-yrs.
- History of chronic alcohol or drug abuse within 12 months.
- Hepatitis B, C or HIV.
See the full eligibility criteria
- Age ≥ 18.
- Documented physician-diagnosed asthma for at least 12 months.
- Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.
- Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months.
- At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
- Pre-BD FEV1 \< 80% predicted normal.
- Objective evidence of asthma as documented.
- Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
- ACQ-6 score ≥ 1.5 at screening and on day of baseline.
- ePRO adherence ≥ 70% in the 7 days prior to randomization.
- Clinically significant pulmonary disease other than asthma.
- History of cancer.
- History of a clinically significant infection.
- Current smokers or participants with smoking history ≥ 10 pack-yrs.
- History of chronic alcohol or drug abuse within 12 months.
- Hepatitis B, C or HIV.
- Pregnant or breastfeeding.
- History of anaphylaxis following any biologic therapy.
- participant assigned by chance in the current study or previous SHR-1905 studies.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.