Asthma With Eosinophilic PhenotypePhase 2NCT05522439
A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype
A Phase 2 study testing SHR-1703 in people with Asthma With Eosinophilic Phenotype, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma With Eosinophilic Phenotype
- What is being tested?
- SHR-1703
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2022to 12 Sep 2024
- 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
- Aged 18 to 75years (inclusive).
- Weight ≥40 kg.
- History of asthma≥ 1 year.
- Documented treatment with Medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization.
- Previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization.
- Blood eosinophils of ≥150 cells/µL at screening and baseline.
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- Pre-Bronchodilator FEV1% pred≥40% and<80% at screening and baseline.
- Asthma Control Questionnaire-6 score≥1.5.
- Use highly effective contraceptive measures.
- Willing to sign the informed consent form to participate in this study.
Who cannot join
- Subjects with Clinically significant pulmonary diseases；
- Subjects with other diseases that could lead to elevated eosinophils；
- Subjects with Immunodeficiency；
- Poorly controlled hypertension;
- Subjects with severe cerebrovascular disease;
- Subjects with infection history requiring clinical intervention；
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- Subjects with parasitic infection；
- Diagnosed Malignant tumor within 5 years prior to randomization;
- Used non-selective β-blockers within 1 week prior to randomization;
- Used either 5-lipoxygenase inhibitor or Phosphodiesterase-4 inhibitor within 1 week prior to randomization;
- Blood donation or massive blood loss, or transfusion of blood products or immunoglobulins within 4 weeks prior to randomization;
- Live attenuated vaccine inoculated within 4 weeks before randomization;
- Allergen Immunotherapy within 8 weeks prior to randomization；
- Used systemic immunosuppressants or immunomodulators, or biologics or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug;
- Bronchial thermoplasty within 1 year prior to randomization；
- Subjects have planned Surgery or other medical procedures that may affect evaluation during the study period;
- Subjects with significant laboratory abnormality at screening；
- Subjects have prolonged QTc interval or other electrocardiogram abnormality with significant safety risk at screening;
- Current smokers or ex-smokers who have given up smoking for <6 months ，or positive smoke test, and/or have a smoking pack history of > 10 pack years;
- History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
- Subjects participated another clinical studies and received active drug within 30 days or 5 half-lives prior to screening;
- Subjects is pregnant, lactating,or planning to become pregnant;
- Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents;
- Other conditions unsuitable for participation in the study per investigator judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Pharmacodynamic, Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1703 in Asthma Patients With Eosinophil Phenotype
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype.
- Conditions
- Asthma With Eosinophilic Phenotype
- Being tested
- SHR-1703, SHR-1703 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1703Drug
SHR-1703 will be administered by SC injection.
SHR-1703 PlaceboDrug
Matching Placebo will be administered by the SC route.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving SHR-1703 dose 1 | Experimental | Not described Receives: Drug: SHR-1703; Drug: SHR-1703 Placebo |
| Subjects receiving SHR-1703 dose 2 | Experimental | Not described Receives: Drug: SHR-1703 |
| Subjects receiving SHR-1703 dose 3 | Experimental | Not described Receives: Drug: SHR-1703; Drug: SHR-1703 Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: SHR-1703 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Blood Eosinophils
Measured: Up to Week 52
Secondary outcomes (12)
Changes from baseline in Pre- and post-Bronchodilator FEV1
Measured: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
Measured: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FVC
Measured: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator PEF
Measured: Up to Week 52
Changes from baseline in n fractional exhaled nitric oxide (FeNO)
Measured: Up to Week 52
Changes from baseline in Asthma Control Questionnaire-6(ACQ-6)
Measured: Up to Week 52
Changes from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ)
Measured: Up to Week 52
Frequency of use of asthma relievers
Measured: Up to Week 24
Frequency of exacerbations of asthma
Measured: Up to Week 24
Frequency of severe exacerbations of asthma
Measured: Up to Week 24
Time to first exacerbation of asthma
Measured: Up to Week 24
Time to first severe exacerbation of asthma
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start22 Dec 2022
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma With Eosinophilic PhenotypeStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522439
- Sponsor's protocol ID
- SHR-1703-201
- Status last verified
- May 2025
- First submitted
- 29 Aug 2022
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Pharmacodynamic, Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1703 in Asthma Patients With Eosinophil Phenotype
- ClinicalTrials.gov ID
- NCT05522439
- Acronym / sponsor ID
- SHR-1703-201
- Conditions
- Asthma With Eosinophilic Phenotype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 31 Aug 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.
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype.
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
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving SHR-1703 dose 1 | Experimental | Drug: SHR-1703, Drug: SHR-1703 Placebo |
| Subjects receiving SHR-1703 dose 2 | Experimental | Drug: SHR-1703 |
| Subjects receiving SHR-1703 dose 3 | Experimental | Drug: SHR-1703, Drug: SHR-1703 Placebo |
| Placebo | Placebo comparator | Drug: SHR-1703 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 to 75years (inclusive).
- Weight ≥40 kg.
- History of asthma≥ 1 year.
- Documented treatment with Medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization.
- Previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization.
Key exclusion criteria (24 listed)
- Subjects with Clinically significant pulmonary diseases；
- Subjects with other diseases that could lead to elevated eosinophils；
- Subjects with Immunodeficiency；
- Poorly controlled hypertension;
- Subjects with severe cerebrovascular disease;
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-1703SHR-1703 will be administered by SC injection. | Drug | Subjects receiving SHR-1703 dose 1, Subjects receiving SHR-1703 dose 2, Subjects receiving SHR-1703 dose 3 |
| SHR-1703 PlaceboMatching Placebo will be administered by the SC route. | Drug | Placebo, Subjects receiving SHR-1703 dose 1, Subjects receiving SHR-1703 dose 3 |
Primary outcome
Changes from baseline in Blood Eosinophils
Time frame: Up to Week 52
12 secondary outcomes
Changes from baseline in Pre- and post-Bronchodilator FEV1
Time frame: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
Time frame: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FVC
Time frame: Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator PEF
Time frame: Up to Week 52
Changes from baseline in n fractional exhaled nitric oxide (FeNO)
Time frame: Up to Week 52
Changes from baseline in Asthma Control Questionnaire-6(ACQ-6)
Time frame: Up to Week 52
Changes from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Up to Week 52
Frequency of use of asthma relievers
Time frame: Up to Week 24
Frequency of exacerbations of asthma
Time frame: Up to Week 24
Frequency of severe exacerbations of asthma
Time frame: Up to Week 24
Time to first exacerbation of asthma
Time frame: Up to Week 24
Time to first severe exacerbation of asthma
Time frame: Up to Week 24
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 28 May 2025.
- 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-1703 in people with Asthma With Eosinophilic Phenotype, run by Jiangsu HengRui Medicine 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 10 inclusion and 24 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 28 May 2025. 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?
Changes from baseline in Blood Eosinophils (time frame: Up to Week 52). 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 28 May 2025.