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Evaluation of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
611 300 mg Q2W
611 450 mg Q2W
Matching placebo
Sponsored by
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent. Male or female adults ages 40 to 85 years old when signing the informed consent. BMI≥16 kg/m2. Documented diagnosis of COPD for at least one year prior to enrolment. Post-bronchodilator FEV1/FVC < 0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%. Current or former smokers with a smoking history of ≥10 pack-years or environmental exposure to biofuel fumes ≥10 years Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment. Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to randomization; Double therapy (LABA + LAMA) allowed if ICS is contraindicated. Patients with blood eosinophils ≥200 cells/microliter at screening. Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose. Exclusion Criteria: Significant pulmonary disease other than COPD (e.g., active tuberculosis,lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc) Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. Diagnosis of α-1 anti-trypsin deficiency. Cor pulmonale, evidence of right cardiac failure Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC). A participant with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. Hypercapnia requiring Bi-level ventilation. AECOPD as defined in inclusion criteria within 4 weeks prior to screening or randomization. History of, or planned pneumonectomy or lung volume reduction surgery. Treatment with oxygen of more than 12 hours per day. Known with allergic or intolerant to mometasone furoate spray or 611/placebo. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

Sites / Locations

  • China-Japan Friendship Hospital
  • Shenzhen People's Hospital
  • Zhongshan Hospital affiliated to Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

group A

group B

placebo group

Arm Description

611 300 mg Q2W, subcutaneous (SC) injection

611 450 mg Q2W, subcutaneous (SC) injection

placebo Q2W, subcutaneous (SC) injection

Outcomes

Primary Outcome Measures

Change from baseline in pre-bronchodilator FEV1 at Week 16
FEV1 is the Forced expiratory volume in one second at study site

Secondary Outcome Measures

Change from baseline in CAT score
Chronic Obstructive Pulmonary Disease assessment tool (CAT)
Change from baseline in SGRQ total score
St. George's Respiratory Questionnaire (SGRQ)
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16
Annualized rate of moderate to severe COPD exacerbations in participants
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD. Moderate:Use of systemic corticosteroids; and/or use of antibiotics; Severe:An inpatient hospitalization due to COPD
Time to first Moderate or severe COPD exacerbation
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD. Moderate:Use of systemic corticosteroids; and/or use of antibiotics; Severe:An inpatient hospitalization due to COPD
Adverse events (AEs), measurement of vital signs,physical examination,electrocardiogram and laboratory tests at each visit.
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations,electrocardiogram,laboratory tests and, etc.
611 Concentration in Serum
The concentration of 611 in Serum
Percentage of Participants with Anti-drug Antibodies and Neutralizing Antibodies
Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%.
Change in serum concentrations of PD variables
PD variables included Pulmonary and activation-regulated chemokine (PARC),IgE,blood eosinophil counts and fibrinogen

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06099652
Brief Title
Evaluation of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official Title
A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase II Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
May 2025 (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
The primary objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
Detailed Description
The maximum study duration was 28 weeks per participants, including a screening period of up to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
611 300 mg Q2W, subcutaneous (SC) injection
Arm Title
group B
Arm Type
Experimental
Arm Description
611 450 mg Q2W, subcutaneous (SC) injection
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo Q2W, subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
611 300 mg Q2W
Intervention Description
611 subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
611 450 mg Q2W
Intervention Description
611 subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
placebo subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Change from baseline in pre-bronchodilator FEV1 at Week 16
Description
FEV1 is the Forced expiratory volume in one second at study site
Time Frame
up to Week 16
Secondary Outcome Measure Information:
Title
Change from baseline in CAT score
Description
Chronic Obstructive Pulmonary Disease assessment tool (CAT)
Time Frame
up to Week 16
Title
Change from baseline in SGRQ total score
Description
St. George's Respiratory Questionnaire (SGRQ)
Time Frame
up to Week 16
Title
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16
Description
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16
Time Frame
up to Week 16
Title
Annualized rate of moderate to severe COPD exacerbations in participants
Description
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD. Moderate:Use of systemic corticosteroids; and/or use of antibiotics; Severe:An inpatient hospitalization due to COPD
Time Frame
up to Week 16
Title
Time to first Moderate or severe COPD exacerbation
Description
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD. Moderate:Use of systemic corticosteroids; and/or use of antibiotics; Severe:An inpatient hospitalization due to COPD
Time Frame
up to Week 16
Title
Adverse events (AEs), measurement of vital signs,physical examination,electrocardiogram and laboratory tests at each visit.
Description
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations,electrocardiogram,laboratory tests and, etc.
Time Frame
Up to 24 Weeks
Title
611 Concentration in Serum
Description
The concentration of 611 in Serum
Time Frame
Up to 24 Weeks
Title
Percentage of Participants with Anti-drug Antibodies and Neutralizing Antibodies
Description
Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%.
Time Frame
Up to 24 Weeks
Title
Change in serum concentrations of PD variables
Description
PD variables included Pulmonary and activation-regulated chemokine (PARC),IgE,blood eosinophil counts and fibrinogen
Time Frame
Up to 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent. Male or female adults ages 40 to 85 years old when signing the informed consent. BMI≥16 kg/m2. Documented diagnosis of COPD for at least one year prior to enrolment. Post-bronchodilator FEV1/FVC < 0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%. Current or former smokers with a smoking history of ≥10 pack-years or environmental exposure to biofuel fumes ≥10 years Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment. Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to randomization; Double therapy (LABA + LAMA) allowed if ICS is contraindicated. Patients with blood eosinophils ≥200 cells/microliter at screening. Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose. Exclusion Criteria: Significant pulmonary disease other than COPD (e.g., active tuberculosis,lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc) Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. Diagnosis of α-1 anti-trypsin deficiency. Cor pulmonale, evidence of right cardiac failure Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC). A participant with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. Hypercapnia requiring Bi-level ventilation. AECOPD as defined in inclusion criteria within 4 weeks prior to screening or randomization. History of, or planned pneumonectomy or lung volume reduction surgery. Treatment with oxygen of more than 12 hours per day. Known with allergic or intolerant to mometasone furoate spray or 611/placebo. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinghong Zhou, BS
Phone
+86 18911301578
Email
zhouqinghong@3sbio.com
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Yang, M.D.
Phone
+8613651380809
Email
dryangting@qq.com
First Name & Middle Initial & Last Name & Degree
Ting Yang, M.D.
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen, M.M.
Phone
+8613902273260
Email
chenrc@vip.163.com
First Name & Middle Initial & Last Name & Degree
Rongchang Chen, M.M.
Facility Name
Zhongshan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanlin Song, M.D.
Phone
+8615021757762
Email
ylsong@163.com
First Name & Middle Initial & Last Name & Degree
Yuanlin Song, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease

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