AsthmaPhase 2NCT05593250
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
A Phase 2 study testing SHR-1905 in people with Asthma, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- SHR-1905
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2023to 21 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- Uncontrolled Diabetes Mellitus
- 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
- Malignancy diagnosed within 5 years before randomization
- Abnormal laboratory tests during screening and baseline
- Positive infectious disease test
- Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject
- Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years
- Drug or alcohol abuse
- Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study
- Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
- Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
- Any other circumstance inappropriate for participating in the clinical trial considered by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510163
About this study
Official title: 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.
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.
- Conditions
- Asthma
- Being tested
- SHR-1905, placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1905Drug
subcutaneous
placeboDrug
subcutaneous ,placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | dose 1 Receives: Drug: SHR-1905 |
| Cohort B | Experimental | dose 2 Receives: Drug: SHR-1905 |
| Cohort C | Experimental | dose 3 Receives: Drug: SHR-1905 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy：Annual asthma exacerbation rate (AAER)
Measured: From randomisation to 48 weeks
Secondary outcomes (12)
Changes of fractional exhaled nitric oxide (FeNO) compared with baseline
Measured: Baseline to72 weeks
Changes from baseline in Asthma Control questionnaire (ACQ-6) scores
Measured: Baseline to 72 weeks
Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores
Measured: Baseline to 72 weeks
AAER associated with hospitalization at 48 weeks
Measured: From randomisation to 48 weeks
Changes from baseline in Asthma Symptom Diary scores
Measured: Baseline to 72 weeks
The proportion of subjects with acute exacerbations of asthma
Measured: Baseline to 72 weeks
Changes from baseline in weekly reliever use
Measured: Baseline to 72 weeks
Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)
Measured: Baseline to 72 weeks
Changes from baseline in weekly mean number of night time awakenings
Measured: Baseline to 72 weeks
Time to the first acute asthma exacerbation
Measured: Baseline to 72 weeks
The proportion of subjects with composite endpoint for asthma (CompEx)
Measured: Baseline to72 weeks
Pharmacokinetics (PK): Serum concentration of SHR-1905
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start17 Jan 2023
- Primary completion5 Dec 2025
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1905 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593250
- Sponsor's protocol ID
- SHR-1905-201
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05593250
- Acronym / sponsor ID
- SHR-1905-201
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- SHR-1905 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: SHR-1905dose 1 |
| Cohort B | Experimental | Drug: SHR-1905dose 2 |
| Cohort C | Experimental | Drug: SHR-1905dose 3 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1905subcutaneous | Drug | Cohort A, Cohort B, Cohort C |
| placebosubcutaneous ,placebo | Drug | Placebo |
Primary outcome
Efficacy：Annual asthma exacerbation rate (AAER)
Time frame: From randomisation to 48 weeks
12 secondary outcomes
Changes of fractional exhaled nitric oxide (FeNO) compared with baseline
Time frame: Baseline to72 weeks
Changes from baseline in Asthma Control questionnaire (ACQ-6) scores
Time frame: Baseline to 72 weeks
Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores
Time frame: Baseline to 72 weeks
AAER associated with hospitalization at 48 weeks
Time frame: From randomisation to 48 weeks
Changes from baseline in Asthma Symptom Diary scores
Time frame: Baseline to 72 weeks
The proportion of subjects with acute exacerbations of asthma
Time frame: Baseline to 72 weeks
Changes from baseline in weekly reliever use
Time frame: Baseline to 72 weeks
Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)
Time frame: Baseline to 72 weeks
Changes from baseline in weekly mean number of night time awakenings
Time frame: Baseline to 72 weeks
Time to the first acute asthma exacerbation
Time frame: Baseline to 72 weeks
The proportion of subjects with composite endpoint for asthma (CompEx)
Time frame: Baseline to72 weeks
Pharmacokinetics (PK): Serum concentration of SHR-1905
Time frame: 72 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1905 in people with Asthma, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy：Annual asthma exacerbation rate (AAER) (time frame: From randomisation to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.