AsthmaPhase 2NCT06680947
A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma
A Phase 2 study testing 610 in people with Asthma, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic 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
- 225 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to Sep 2027
- Phase
- Phase 2
- 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
- 1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
- 2. Female and male aged 18 to 75 years.
- 3. Diagnosed with asthma for ≥12 months that meet GINA.
- 4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
- 5. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
- 6. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.
Who cannot join
- 1. Presence of a known pre-existing, clinically important lung condition other than Asthma.
- 2. Severe asthma exacerbation within 4 weeks prior to randomization.
- 3. Subjects with any eosinophilic diseases other than asthma.
- 4. Known, pre-existing severe or clinically significant cardiovascular disease.
- 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
- 6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- 7. Subjects with allergy/intolerance to a monoclonal antibody.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 weeks and follow-up period of 8 weeks.
- 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
Subcutaneously injection.
610Drug
Subcutaneously injection.
PlaceboDrug
Subcutaneously injection.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects will receive 610 for 52 weeks. Receives: Drug: 610 |
| Group B | 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.
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Measured: Baseline (Day 1) and at week 52
Secondary outcomes (7)
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Measured: Baseline (Day 1) and at week 16
Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12,16, 20, 28, 36, 44, 52
Percentage of FEV1 will be measured using spirometry.
Measured: Baseline (Day 1) and at week 4, 8,12,16, 20, 28, 36, 44, 52
Number of asthma exacerbation through study week 52
Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period
Measured: From baseline (Day 1) to week 52
Number of asthma exacerbations requiring hospitalization or emergency room visits
Asthma exacerbations that are associated with a hospitalization or an emergency room visit.
Measured: From baseline (Day 1) to week 52
Change from baseline in Asthma Control Questionnaire (ACQ) score.
The ACQ contains five symptom questions (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze), one bronchodilator question and pre-bronchodilator FEV1 level. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ score is the average of the responses. Higher score indicates more limitations.
Measured: From baseline (Day 1) to week 52
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)
The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best.
Measured: From baseline (Day 1) to week 52
Assessment of adverse events (AEs)
Number of participants with adverse events (AEs)
Measured: Up to week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start20 Dec 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Zhang, Doctor, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680947
- Sponsor's protocol ID
- SSGJ-610-BA-II-02
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2024
- Last updated
- 29 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 29 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 IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma
- ClinicalTrials.gov ID
- NCT06680947
- Acronym / sponsor ID
- SSGJ-610-BA-II-02
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Nov 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.
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 weeks and follow-up period of 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: 610Subjects will receive 610 for 52 weeks. |
| Group B | 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 (6 listed)
- 1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
- 2. Female and male aged 18 to 75 years.
- 3. Diagnosed with asthma for ≥12 months that meet GINA.
- 4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
- 5. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
Key exclusion criteria (7 listed)
- 1. Presence of a known pre-existing, clinically important lung condition other than Asthma.
- 2. Severe asthma exacerbation within 4 weeks prior to randomization.
- 3. Subjects with any eosinophilic diseases other than asthma.
- 4. Known, pre-existing severe or clinically significant cardiovascular disease.
- 5. 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 |
|---|---|---|
| 610Subcutaneously injection. | Drug | Group A |
| 610Subcutaneously injection. | Drug | Group B |
| PlaceboSubcutaneously injection. | Drug | Placebo group |
Primary outcome
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52
Time frame: Baseline (Day 1) and at week 52
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
7 secondary outcomes
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16
Time frame: Baseline (Day 1) and at week 16
Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12,16, 20, 28, 36, 44, 52
Time frame: Baseline (Day 1) and at week 4, 8,12,16, 20, 28, 36, 44, 52
Number of asthma exacerbation through study week 52
Time frame: From baseline (Day 1) to week 52
Number of asthma exacerbations requiring hospitalization or emergency room visits
Time frame: From baseline (Day 1) to week 52
Change from baseline in Asthma Control Questionnaire (ACQ) score.
Time frame: From baseline (Day 1) to week 52
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)
Time frame: From baseline (Day 1) to week 52
Assessment of adverse events (AEs)
Time frame: Up to week 60
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 29 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. This study is not recruiting at the moment.
Min Zhang, Doctor 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 2 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 6 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: under way, not looking for participants, as of the sponsor's last update on 29 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 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?
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?
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52 (time frame: Baseline (Day 1) and at 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 29 Jan 2026.