Back to resultsA Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma
Primary Purpose
Asthma
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
610 30mg group
610 100mg group
610 300mg group
Placebo 30mg group
Placebo 100mg group
Placebo 300mg group
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Eosinophilic asthma, Exacerbations, 610, Placebo
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with asthma for ≥12 months
- Within 3 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.）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
- In the past 12 months prior to screening， at least one time asthma exacerbations history
- Pre-bronchodilator FEV1 <80% predicted value
- Asthma-related blood eosinophils ≥ 150 cells/μL within 3 months before administration
Exclusion Criteria:
- 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 7 day before screening
- Parasitic infection within 6 months before screening
- 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 of anti IL-4Ror 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
Sites / Locations
- Shanghai General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
610 30mg group
610 100mg group
610 300mg group
Placebo 30mg group
Placebo 100mg group
Placebo 300mg group
Arm Description
610 30 mg administered subcutaneously every 4 weeks
610 100 mg administered subcutaneously every 4 weeks
610 300mg administered subcutaneously every 4 weeks
placebo subcutaneous (SC) Q4W，8 times
placebo subcutaneous (SC) Q4W，8 times
placebo subcutaneous (SC) Q4W，8 times
Outcomes
Primary Outcome Measures
Adverse events(AEs)
The incidence and severity of AEs, including SAEs, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations#electrocardiogram#laboratory tests and, etc.
Secondary Outcome Measures
Pharmacokinetics-Tmax
Time to Cmax of 610
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after 610 subcutaneous
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after 610 subcutaneous
Pharmacokinetics-Cmax
Maximum observed concentration of 610
Pharmacokinetics-CL/F
Apparent clearance of 610
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of 610
Pharmacokinetics-t1/2
Terminal elimination half-life of 610
Pharmacodynamics-Eosinophils
Absolute eosinophils account and change from baseline in percentage
Anti-drug-antibody
The percentage of subjects with positive ADA titers over time for 610
Number of asthma exacerbation
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.
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Percentage of FEV1 will be measured using spirometry.
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.
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.
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)
Asthma exacerbations that are associated with a hospitalization.
Change from baseline in Asthma Control Questionnaire score
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).
Change From Baseline in the St. George's Respiratory Questionnaire Total Score
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.
Full Information
NCT ID
NCT05584306
First Posted
October 9, 2022
Last Updated
October 17, 2022
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05584306
Brief Title
A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy 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 safety, tolerability, pharmacokinetics and preliminary efficacy of 610 in adults with severe eosinophilic asthma. Plan to recruit 24 subjects, and the subjects divided into 3 groups: 610 30mg group，100mg group, 610 300mg group，8 subjects in each dose group, of which 6 received the trial drug and 2 received placebo. The study is divided into screening period of 2 weeks, treatment period of 32 weeks and follow-up period of 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Eosinophilic asthma, Exacerbations, 610, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
610 30mg group
Arm Type
Experimental
Arm Description
610 30 mg administered subcutaneously every 4 weeks
Arm Title
610 100mg group
Arm Type
Experimental
Arm Description
610 100 mg administered subcutaneously every 4 weeks
Arm Title
610 300mg group
Arm Type
Experimental
Arm Description
610 300mg administered subcutaneously every 4 weeks
Arm Title
Placebo 30mg group
Arm Type
Placebo Comparator
Arm Description
placebo subcutaneous (SC) Q4W，8 times
Arm Title
Placebo 100mg group
Arm Type
Placebo Comparator
Arm Description
placebo subcutaneous (SC) Q4W，8 times
Arm Title
Placebo 300mg group
Arm Type
Placebo Comparator
Arm Description
placebo subcutaneous (SC) Q4W，8 times
Intervention Type
Drug
Intervention Name(s)
610 30mg group
Intervention Description
610 30mg subcutaneous (SC) Q4W，8 times
Intervention Type
Drug
Intervention Name(s)
610 100mg group
Intervention Description
610 100mg subcutaneous (SC) Q4W，8 times
Intervention Type
Drug
Intervention Name(s)
610 300mg group
Intervention Description
610 300mg subcutaneous (SC) Q4W，8 times
Intervention Type
Other
Intervention Name(s)
Placebo 30mg group
Intervention Description
placebo subcutaneous (SC) Q4W，8 times
Intervention Type
Other
Intervention Name(s)
Placebo 100mg group
Intervention Description
placebo subcutaneous (SC) Q4W，8 times
Intervention Type
Other
Intervention Name(s)
Placebo 300mg group
Intervention Description
placebo subcutaneous (SC) Q4W，8 times
Primary Outcome Measure Information:
Title
Adverse events(AEs)
Description
The incidence and severity of AEs, including SAEs, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations#electrocardiogram#laboratory tests and, etc.
Time Frame
From Day 0 to Day 308
Secondary Outcome Measure Information:
Title
Pharmacokinetics-Tmax
Description
Time to Cmax of 610
Time Frame
From Day 0 to Day 308
Title
Pharmacokinetics-AUC0-last
Description
Area under the concentration-time curve from time 0 to last time point after 610 subcutaneous
Time Frame
From Day 0 to Day 308
Title
Pharmacokinetics-AUC0-inf
Description
Area under the concentration-time curve from time 0 to infinity after 610 subcutaneous
Time Frame
From Day 0 to Day 308
Title
Pharmacokinetics-Cmax
Description
Maximum observed concentration of 610
Time Frame
From Day 0 to Day 308
Title
Pharmacokinetics-CL/F
Description
Apparent clearance of 610
Time Frame
From Day 0 to Day 308
Title
Pharmacokinetics-Vz/F
Description
Apparent volume of distribution during terminal phase of 610
Time Frame
From Day 0 to Day 308
Title
Pharmacokinetics-t1/2
Description
Terminal elimination half-life of 610
Time Frame
From Day 0 to Day 308
Title
Pharmacodynamics-Eosinophils
Description
Absolute eosinophils account and change from baseline in percentage
Time Frame
From Day 0 to Day 308
Title
Anti-drug-antibody
Description
The percentage of subjects with positive ADA titers over time for 610
Time Frame
From Day 0 to Day 308
Title
Number of asthma exacerbation
Description
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.
Time Frame
From Day 0 to Day 308
Title
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Description
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Time Frame
From Day 0 to Day 308
Title
Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Description
Percentage of FEV1 will be measured using spirometry.
Time Frame
From Day 0 to Day 308
Title
Time to first asthma exacerbation event
Description
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.
Time Frame
From Day 0 to Day 308
Title
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)
Description
Asthma exacerbations that are associated with a hospitalization or an emergency room visit.
Time Frame
From Day 0 to Day 308
Title
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)
Description
Asthma exacerbations that are associated with a hospitalization.
Time Frame
From Day 0 to Day 308
Title
Change from baseline in Asthma Control Questionnaire score
Description
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).
Time Frame
From Day 0 to Day 308
Title
Change From Baseline in the St. George's Respiratory Questionnaire Total Score
Description
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.
Time Frame
From Day 0 to Day 308
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with asthma for ≥12 months
Within 3 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.）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
In the past 12 months prior to screening， at least one time asthma exacerbations history
Pre-bronchodilator FEV1 <80% predicted value
Asthma-related blood eosinophils ≥ 150 cells/μL within 3 months before administration
Exclusion Criteria:
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 7 day before screening
Parasitic infection within 6 months before screening
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 of anti IL-4Ror 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinghong Zhou, MD
Organizational Affiliation
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xin Zhou, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min Zhang, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma
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