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Asthma With Eosinophilic PhenotypePhase 3NCT06653322

A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma

A Phase 3 study testing HR-1703 in people with Asthma With Eosinophilic Phenotype, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 12 years and older
Conditions the study is for
Asthma With Eosinophilic Phenotype
What is being tested?
HR-1703
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
401 participants
Where
1 siteChina
Study dates
21 Nov 2024to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • At least 12 years of age
  • A minimum weight of 40kg
  • A medical history of at least 1 year that meets the diagnosis of asthma;
  • Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
  • Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
  • Absolute count of blood eosinophils suggests eosinophilic asthma
Show all 12Show fewer
  • During the screening period and baseline, pre- BD FEV1% < 80%
  • During the screening period and baseline, ACQ-6 score indicates asthma poor control
  • History of severe asthma exacerbation within the past 12 months prior to screening
  • Good compliance with eDiary completion
  • Take efficient contraceptive measures
  • Voluntarily sign the informed consent form to participate in this study

Who cannot join

  • With other condition that could lead to elevated eosinophils
  • With Clinically significant pulmonary diseases
  • With existing immunodeficiency disease
  • With other clinically significant diseases that may affect lung function
  • With uncontrolled severe cardiovascular and cerebrovascular diseases
  • With uncontrolled hypertension and/or diabetes
Show all 19Show fewer
  • With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
  • Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
  • Existing parasitic infections
  • Diagnosed as malignant tumor within the first 5 years of randomization
  • Significant abnormalities in screening period or baseline laboratory tests
  • Screening period or baseline ECG QTc prolongation
  • Prohibited drugs using during the pre randomization period
  • Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening
  • Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
  • History of drug use, alcoholism, or substance abuse within the past year prior to screening
  • Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
  • Pregnant or lactating subjects
  • Other reasons why the researcher deemed it unsuitable for conducting this experiment

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China School of Medicine West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Being tested
HR-1703, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HR-1703Drug

    HR-1703 will be administered by SC injection.

  • PlaceboDrug

    Matching Placebo will be administered by the SC injection.

Study groups in NCT06653322
Study groupRoleWhat they receive
Subjects receiving SHR-1703 dose 1ExperimentalNot described
Receives: Drug: HR-1703
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualised asthma exacerbation rate，about 48weeks

    Measured: about 48weeks

Secondary outcomes (16)

  1. Mean number of days with oral corticosteroids taken for exacerbation，about 48weeks

    Measured: about 48weeks

  2. Frequency of exacerbations requiring hospitalisation，about 48weeks

    Measured: about 48weeks

  3. Time to first exacerbation requiring hospitalisation，about 48weeks

    Measured: about 48weeks

  4. Mean change from baseline in clinic pre- and post-BD FEV1，about 64 weeks

    Measured: about 64 weeks

  5. Mean change from baseline in clinic pre- and post-BD FEV1%，about 64weeks

    Measured: about 64weeks

  6. Mean change from baseline in clinic pre- and post-BD FVC，about 64 weeks

    Measured: about 64 weeks

  7. Mean change from baseline in clinic pre- and post-BD PEF，about 64 weeks

    Measured: about 64 weeks

  8. Mean change from baseline in FeNO，about 64weeks

    Measured: about 64weeks

  9. Mean change from baseline in asthma control questionnaire (ACQ-6) score，about 64 weeks

    Measured: about 64 weeks

  10. Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score，about 64weeks

    Measured: about 64weeks

  11. Mean change from baseline in Asthma symptom score at week 12/24/36/48/60，about 64weeks

    Measured: at week 12/24/36/48/60，about 64weeks

  12. Mean change from baseline in daily rescue medication use at week 12/24/36/48/60，about 64weeks

    Measured: at week 12/24/36/48/60，about 64weeks

  13. Mean change from baseline in awakening at night due to asthma symptoms requiring rescue medication use at week 12/24/36/48/60，about 64weeks

    Measured: at week 12/24/36/48/60，about 64weeks

  14. Mean change from baseline in morning and evening PEF at week 12/24/36/48/60，about 64weeks

    Measured: at week 12/24/36/48/60，about 64weeks

  15. Mean change from baseline in IgE，about 64weeks

    Measured: about 64weeks

  16. Adverse events，about 64weeks

    Measured: about 64weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2024
  2. Study start21 Nov 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06653322
Sponsor's protocol ID
SHR-1703-302
Status last verified
Dec 2025
First submitted
20 Oct 2024
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HR-1703 in people with Asthma With Eosinophilic Phenotype, run by Guangdong 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 12 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Annualised asthma exacerbation rate，about 48weeks (time frame: about 48weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06653322.

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 10 Aug 2026.

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