AsthmaPhase 2NCT05528679
A Phase II Study of 610 in Participants With Severe Eosinophilic Asthma
A Phase 2 study testing 610 100mg and 610 300mg in people with Asthma, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study will assess the efficacy 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 100mg and 610 300mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Sep 2023
- 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
- Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study
- Female and male aged 18 to 75 years
- Diagnosed with asthma for ≥12 months that meet GINA
- Within 6 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily. ICS can be included in In the ICS/LABA combination preparation）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
- Current treatment with maintenance oral corticosteroids (OCS), prednisone dosage must be ≤10 mg, or equivalent, daily, and stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
- In the past 12 months prior to screening， two or more asthma exacerbations history, or at least one time emergency department (ED) visits and/or ICU and/or hospitalization
Show all 11Show fewer
- Pre-bronchodilator FEV1 <80% predicted value
- Positive of bronchodilator test or positive of bronchial provocation test
- Asthma Control Questionnaire score ≥1.5
- Asthma-related blood eosinophils ≥ 300 cells/μL within 6 months before screening, or asthma-related blood eosinophils ≥ 150 cells/μL at screening
- Male and their partners or female must commit to correct use of one or more effective contraceptive measures of the duration of the trial and for 6 months after the last study drug administration. No fertility, sperm donation, or egg donation plans for at least 6 months after the last study drug administration
Who cannot join
- With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
- With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
- In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
- with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
- poorly controlled systemic disease
- Active infection that requiring systemic treatment at screening
Show all 17Show fewer
- Parasitic infection without adequate treatment within 6 months before screening
- Lymphoproliferative disease or any malignancy history within past 5 years prior to screening (Except for received treatment and no recurrence in the past 3 months include basal cell carcinoma, actinic keratosis, carcinoma in situ of cervix, or resected non-invasive malignant colonic polyps.)
- Liver function meets one of the following criteria at screening or before randomization: a) Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) ≥ 2.0×ULN (upper limit of normal); b) Total bilirubin≥1.5×ULN
- At screening, HBsAg or HCV Ab or HIV Ab or TP Ab positive; HBsAg or HCV Ab positive need to be further tested of HBV DNA titer detection or HCV RNA detection (More than normal value range needs to be excluded)
- Subjects who have received any monoclonal antibody treatment within 3 months or 5 half-lives (whichever is longer) before screening, or with poor treatment effect of anti-IL-5/5R
- Vaccination history with live vaccines (including live attenuated vaccines) within 4 weeks before screening, or plan to receive during of the trial
- Participated in any interventional clinical trial and received intervention within 3 months before screening
- Allergy/intolerance to investigational medicinal product.
- Current smokers with average monthly smoking of ≥10 cigarettes within 6 months before screening, or former smokers with a smoking history of ≥10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked)
- Plan to pregnant during of the trial or pregnant or breastfeeding
- Any other things that are not suitable for participating in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Min Zhang, Doctor, 13482345145, 13482345145@163.com
Xin Zhou, Bachelor, 13701756821, xzhou53@163.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II, Efficacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma
This study will assess the efficacy 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 efficacy and safety of 610 in adults with severe eosinophilic asthma. Plan to recruit 120 subjects, and the subjects divided into 3 groups: 610 100mg group, 610 300mg group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks and follow-up period of 8 weeks.
- Conditions
- Asthma
- Being tested
- 610 100mg, 610 300mg, placebo
- Keywords
- Asthma, Eosinophilic asthma, Exacerbations, 610, Placebo
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
610 100mgDrug
100mg administered subcutaneously Q4W
610 300mgDrug
300mg administered subcutaneously Q4W
placeboDrug
administered subcutaneously Q4W
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | 610 100 mg administered subcutaneously every 4 weeks Receives: Drug: 610 100mg |
| Treatment group B | Experimental | 610 300 mg administered subcutaneously every 4 weeks Receives: Drug: 610 300mg |
| placebo Arm Type：no inter | Placebo comparator | placebo administered subcutaneously every 4 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 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
Secondary outcomes (9)
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, and 12
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 4,8,12
Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, 12, 16
Percentage of FEV1 will be measured using spirometry.
Measured: Baseline (Day 1) and at week 4,8,12
Number of asthma exacerbation through study week 16
Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.
Measured: From baseline (Day 1) to week 16
Time to first asthma exacerbation event
Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.
Measured: From baseline (Day 1) to week 16
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)
Asthma exacerbations that are associated with a hospitalization or an emergency room visit.
Measured: From baseline (Day 1) to week 16
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)
Asthma exacerbations that are associated with a hospitalization.
Measured: From baseline (Day 1) to week 16
Puffs of rescue medication for asthma exacerbations
Albuterol or levalbuterol for an asthma exacerbation is considered rescue medication.
Measured: From baseline (Day 1) to week 16
Change from baseline in Asthma Control Questionnaire score at week 4,8,12,16
The ACQ has 7 questions- the first 5 items assess the most common asthma symptoms plus 6. short-acting bronchodilator use and 7. FEV1 (pre-bronchodilator use, % and % predicted use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6= maximum impairment).
Measured: Baseline (Day 1) and at week 4,8,12,16
Change From Baseline in the St. George's Respiratory Questionnaire Total Score at week 16
The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health.
Measured: Baseline (Day 1) and at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinghong Zhou, MD, Study director, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Min Zhang, MD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineXin Zhou, MD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528679
- Sponsor's protocol ID
- SSGJ-610-BA-II-01
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- 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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II, Efficacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT05528679
- Acronym / sponsor ID
- SSGJ-610-BA-II-01
- Conditions
- Asthma
- Keywords
- Asthma, Eosinophilic asthma, Exacerbations, 610, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 6 Sep 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 will assess the efficacy 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 efficacy and safety of 610 in adults with severe eosinophilic asthma. Plan to recruit 120 subjects, and the subjects divided into 3 groups: 610 100mg group, 610 300mg group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 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 |
|---|---|---|
| Treatment group A | Experimental | Drug: 610 100mg610 100 mg administered subcutaneously every 4 weeks |
| Treatment group B | Experimental | Drug: 610 300mg610 300 mg administered subcutaneously every 4 weeks |
| placebo Arm Type：no inter | Placebo comparator | Drug: placeboplacebo administered subcutaneously every 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study
- Female and male aged 18 to 75 years
- Diagnosed with asthma for ≥12 months that meet GINA
- Within 6 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily. ICS can be included in In the ICS/LABA combination preparation）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
- Current treatment with maintenance oral corticosteroids (OCS), prednisone dosage must be ≤10 mg, or equivalent, daily, and stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
Key exclusion criteria (17 listed)
- With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
- With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
- In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
- with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
- poorly controlled systemic 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 |
|---|---|---|
| 610 100mg100mg administered subcutaneously Q4W | Drug | Treatment group A |
| 610 300mg300mg administered subcutaneously Q4W | Drug | Treatment group B |
| placeboadministered subcutaneously Q4W | Drug | placebo Arm Type：no inter |
Primary outcome
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16
Time frame: Baseline (Day 1) and 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.
9 secondary outcomes
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, and 12
Time frame: Baseline (Day 1) and at week 4,8,12
Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, 12, 16
Time frame: Baseline (Day 1) and at week 4,8,12
Number of asthma exacerbation through study week 16
Time frame: From baseline (Day 1) to week 16
Time to first asthma exacerbation event
Time frame: From baseline (Day 1) to week 16
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)
Time frame: From baseline (Day 1) to week 16
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)
Time frame: From baseline (Day 1) to week 16
Puffs of rescue medication for asthma exacerbations
Time frame: From baseline (Day 1) to week 16
Change from baseline in Asthma Control Questionnaire score at week 4,8,12,16
Time frame: Baseline (Day 1) and at week 4,8,12,16
Change From Baseline in the St. George's Respiratory Questionnaire Total Score at week 16
Time frame: Baseline (Day 1) and at week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- 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.
Qinghong Zhou, MD study director
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Min Zhang, MD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Xin Zhou, MD 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 100mg and 610 300mg 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 11 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 6 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Zhou, MD (18911301578, zhouqinghong@3sbio.com), or a site near the patient. 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 16 (time frame: Baseline (Day 1) and at week 16). 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 6 Sep 2022.