Back to resultsA Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Primary Purpose
Asthma
Status
Enrolling by invitation
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1905
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Male or female aged between 18 and 75 years (inclusive)
- Weight ≥ 40 kg
- Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
- Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization
- At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
- No birth plan and must agree to take effective contraceptive methods
- Sign informed consent form voluntarily for the trial
Exclusion Criteria:
- Any clinically important pulmonary disease
- Any disease other than asthma that may affect lung function
- Any disease other than asthma related to elevation of eosinophils
- Any immunodeficiency disease
- Any clinically important serious cardiovascular diseases unstable or uncontrolled
- Uncontrolled Hypertension
- Uncontrolled Diabetes Mellitus
- Any clinically important infections within 4 weeks before randomization
- Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that the investigator think affect the evaluation of the subjects
- Any parasitic infections within 6 months before randomization
- Malignancy diagnosed within 5 years before randomization
- Abnormal laboratory tests during screening and baseline
- Positive infectious disease test
- Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may causesafety risk to the subject
- Current smoker or smoking cessation for less than 6 months at screening, and/or positive nicotine test during screening，or smoking history ≥10 pack- years
- Positive alcohol breath test and positive urine drug test at screening
- Allergy history to any biological or other agent that investigator think the subject should not participate in the study
- Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
- Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
- Any other circumstance judged by the investigatorinappropriate for participating in the clinical trial
Sites / Locations
- The First Affiliated Hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Cohort A
Cohort B
Cohort C
Placebo
Arm Description
dose 1
dose 2
dose 3
Outcomes
Primary Outcome Measures
Efficacy：Annual asthma exacerbation rate (AAER)
Secondary Outcome Measures
Changes from baseline in forced expiratory volume in one second (FEV1)
Changes from baseline in forced vital capacity (FVC)
Changes from baseline in peak expiratory flow (PEF) pre/post-bronchodilator (pre/ post-BD)
Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at each evaluation time
Changes of blood eosinophils (EOS) compared with baseline at each evaluation time
Changes of serum immunoglobulin E (IgE) compared with baseline at each evaluation time
Changes from baseline in Asthma Control questionnaire (ACQ-6) scores
Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores
AAER associated with hospitalization at 48 weeks
Changes from baseline in weekly mean daily Asthma Symptom Diary scores
The proportion of subjects with acute exacerbations of asthma
Changes from baseline in weekly reliever use
Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)
Changes from baseline in weekly mean number of night time awakenings
Time to the first acute asthma exacerbation
Changes of the Sino-Nasal Outcome Test-22-item (SNOT-22) score in patients with nasal polyps at each evaluation time
The proportion of subjects with composite endpoint for asthma (CompEx)
Safety: Adverse events
Safety: Serious adverse events
Pharmacokinetics (PK): Serum concentration of SHR-1905
Immunogenicity: The incidence of anti-drug antibody (ADA)
Immunogenicity: The timing of anti-drug antibody (ADA)
Immunogenicity: The duration of anti-drug antibody (ADA)
Immunogenicity: The titer of anti-drug antibody (ADA)
Full Information
NCT ID
NCT05593250
First Posted
October 14, 2022
Last Updated
February 1, 2023
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05593250
Brief Title
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Official Title
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a phase 2 study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
SHR-1905 compared with placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Description
dose 1
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
dose 2
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
dose 3
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-1905
Intervention Description
subcutaneous
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subcutaneous ,placebo
Primary Outcome Measure Information:
Title
Efficacy：Annual asthma exacerbation rate (AAER)
Time Frame
From randomisation to 48 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in forced expiratory volume in one second (FEV1)
Time Frame
From randomisation to 72 weeks
Title
Changes from baseline in forced vital capacity (FVC)
Time Frame
From randomisation to 72 weeks
Title
Changes from baseline in peak expiratory flow (PEF) pre/post-bronchodilator (pre/ post-BD)
Time Frame
From randomisation to 72 weeks
Title
Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at each evaluation time
Time Frame
Baseline to72 weeks
Title
Changes of blood eosinophils (EOS) compared with baseline at each evaluation time
Time Frame
Baseline to72 weeks
Title
Changes of serum immunoglobulin E (IgE) compared with baseline at each evaluation time
Time Frame
Baseline to72 weeks
Title
Changes from baseline in Asthma Control questionnaire (ACQ-6) scores
Time Frame
Baseline to 72 weeks
Title
Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores
Time Frame
Baseline to 72 weeks
Title
AAER associated with hospitalization at 48 weeks
Time Frame
From randomisation to 48 weeks
Title
Changes from baseline in weekly mean daily Asthma Symptom Diary scores
Time Frame
Baseline to 72 weeks
Title
The proportion of subjects with acute exacerbations of asthma
Time Frame
Baseline to 72 weeks
Title
Changes from baseline in weekly reliever use
Time Frame
Baseline to 72 weeks
Title
Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF)
Time Frame
Baseline to 72 weeks
Title
Changes from baseline in weekly mean number of night time awakenings
Time Frame
Baseline to 72 weeks
Title
Time to the first acute asthma exacerbation
Time Frame
Baseline to 72 weeks
Title
Changes of the Sino-Nasal Outcome Test-22-item (SNOT-22) score in patients with nasal polyps at each evaluation time
Time Frame
Baseline to 72 weeks
Title
The proportion of subjects with composite endpoint for asthma (CompEx)
Time Frame
Baseline to72 weeks
Title
Safety: Adverse events
Time Frame
Baseline to 72 weeks
Title
Safety: Serious adverse events
Time Frame
Baseline to 72 weeks
Title
Pharmacokinetics (PK): Serum concentration of SHR-1905
Time Frame
72 weeks
Title
Immunogenicity: The incidence of anti-drug antibody (ADA)
Time Frame
72 weeks
Title
Immunogenicity: The timing of anti-drug antibody (ADA)
Time Frame
72 weeks
Title
Immunogenicity: The duration of anti-drug antibody (ADA)
Time Frame
72 weeks
Title
Immunogenicity: The titer of anti-drug antibody (ADA)
Time Frame
72 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged between 18 and 75 years (inclusive)
Weight ≥ 40 kg
Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization
At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
No birth plan and must agree to take effective contraceptive methods
Sign informed consent form voluntarily for the trial
Exclusion Criteria:
Any clinically important pulmonary disease
Any disease other than asthma that may affect lung function
Any disease other than asthma related to elevation of eosinophils
Any immunodeficiency disease
Any clinically important serious cardiovascular diseases unstable or uncontrolled
Uncontrolled Hypertension
Uncontrolled Diabetes Mellitus
Any clinically important infections within 4 weeks before randomization
Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that the investigator think affect the evaluation of the subjects
Any parasitic infections within 6 months before randomization
Malignancy diagnosed within 5 years before randomization
Abnormal laboratory tests during screening and baseline
Positive infectious disease test
Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may causesafety risk to the subject
Current smoker or smoking cessation for less than 6 months at screening, and/or positive nicotine test during screening，or smoking history ≥10 pack- years
Positive alcohol breath test and positive urine drug test at screening
Allergy history to any biological or other agent that investigator think the subject should not participate in the study
Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
Any other circumstance judged by the investigatorinappropriate for participating in the clinical trial
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510163
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
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