NCT05593250CompletedPhase 2
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma.
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 14 Oct 2022
- Start date
- 17 Jan 2023
- Primary completion date
- 5 Dec 2025
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Diseases
- Asthma
- NCT number
- NCT05593250
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 260
- From 17 Jan 2023 to the primary completion date, 5 Dec 2025
- 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
- Any clinically important infections within 4 weeks before randomization
- Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that may affect the evaluation of the subjects considered by the investigator
- Any parasitic infections within 6 months before randomization
- Drug or alcohol abuse
- Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
Other illness
- Any clinically important pulmonary disease
- Any disease other than asthma that may affect lung function
- Any disease other than asthma related to elevation of eosinophils
- Any immunodeficiency disease
- Any clinically important serious cardiovascular diseases unstable or uncontrolled
- Uncontrolled Hypertension
- Uncontrolled Diabetes Mellitus
- Malignancy diagnosed within 5 years before randomization
- Positive infectious disease test
- Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study
Lab values
- Abnormal laboratory tests during screening and baseline
- Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject
Other
- Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years
- Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
- Any other circumstance inappropriate for participating in the clinical trial considered by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · 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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.