NCT07098403RecruitingPhase 3
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase Ⅲ Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 408 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- 3 Sept 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- Asthma
- NCT number
- NCT07098403
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 408
- From 3 Sept 2025 to the primary completion date, 31 Jan 2028
- 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
- participant randomized in the current study or previous SHR-1905 studies.
Other illness
- Clinically significant pulmonary disease other than asthma.
- History of cancer.
- History of a clinically significant infection.
- History of chronic alcohol or drug abuse within 12 months.
- Hepatitis B, C or HIV.
- History of anaphylaxis following any biologic therapy.
Other
- Current smokers or participants with smoking history ≥ 10 pack-yrs.
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 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 |
|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.