AsthmaPhase 3NCT06323213
Efficacy and Safety Study of 610 in Patients With Severe Asthma
A Phase 3 study testing 610 in people with Asthma, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe 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?
- 610
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2024to Sep 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give written informed consent prior to participation in the study.
- Male or female adults ages 18 to 75 years old when signing the informed consent.
- Documented diagnosis of asthma for at least one year prior to screening.
- History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
Who cannot join
- Presence of a known pre-existing, clinically important lung condition other than asthma.
- Severe asthma exacerbation within 4 weeks prior to randomization.
- Subjects with any eosinophilic diseases other than asthma.
- Known, pre-existing severe or clinically significant cardiovascular disease.
- known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
- Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- Subjects with allergy/intolerance to a monoclonal antibody.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
Read the detailed description
The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.
- Conditions
- Asthma
- Being tested
- 610, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
610Drug
610 subcutaneously injection.
PlaceboDrug
Placebo subcutaneously injection.
| Study group | Role | What they receive |
|---|---|---|
| 610 group | Experimental | Subjects will receive 610 for 52 weeks. Receives: Drug: 610 |
| placebo group | Placebo comparator | Subjects will receive placebo for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of severe exacerbation events
Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period
Measured: Up to 52 weeks
Secondary outcomes (6)
Time to first severe exacerbation event
Time to first severe exacerbation event during the 52-week placebo-controlled treatment period
Measured: Up to 52 weeks
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period
Measured: Up to 52 weeks
Change from baseline in ACQ score
Change from baseline to week 52 in ACQ score
Measured: Up to 52 weeks
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)
Change from baseline to week 52 in SGRQ score
Measured: Up to 52 weeks
Change in pre-bronchodilator forced expiratory volume (FEV1)
Absolute change from baseline to week 52 in pre-bronchodilator FEV1
Measured: Up to 52 weeks
Assessment of adverse events (AEs)
Number of participants with adverse events (AEs)
Measured: Up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start24 Jun 2024
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
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 Sunshine Guojian Pharmaceutical (Shanghai) 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Zhang, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineXin Zhou, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323213
- Sponsor's protocol ID
- SSGJ-610-BA-III-01
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT06323213
- Acronym / sponsor ID
- SSGJ-610-BA-III-01
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 21 Mar 2024 (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 primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
Detailed description
The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 610 group | Experimental | Drug: 610Subjects will receive 610 for 52 weeks. |
| placebo group | Placebo comparator | Drug: PlaceboSubjects will receive placebo for 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to give written informed consent prior to participation in the study.
- Male or female adults ages 18 to 75 years old when signing the informed consent.
- Documented diagnosis of asthma for at least one year prior to screening.
- History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
Key exclusion criteria (7 listed)
- Presence of a known pre-existing, clinically important lung condition other than asthma.
- Severe asthma exacerbation within 4 weeks prior to randomization.
- Subjects with any eosinophilic diseases other than asthma.
- Known, pre-existing severe or clinically significant cardiovascular disease.
- known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
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 |
|---|---|---|
| 610610 subcutaneously injection. | Drug | 610 group |
| PlaceboPlacebo subcutaneously injection. | Drug | placebo group |
Primary outcome
Annualized rate of severe exacerbation events
Time frame: Up to 52 weeks
Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period
6 secondary outcomes
Time to first severe exacerbation event
Time frame: Up to 52 weeks
Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
Time frame: Up to 52 weeks
Change from baseline in ACQ score
Time frame: Up to 52 weeks
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)
Time frame: Up to 52 weeks
Change in pre-bronchodilator forced expiratory volume (FEV1)
Time frame: Up to 52 weeks
Assessment of adverse events (AEs)
Time frame: Up to 60 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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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.
Min Zhang principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Xin Zhou principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 610 in people with Asthma, run by Sunshine Guojian Pharmaceutical (Shanghai) 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Jan 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?
Contact Qinghong Zhou, MD (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of severe exacerbation events (time frame: Up to 52 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 7 Jan 2026.