Back to resultsThe Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps
Primary Purpose
Chronic Rhinosinusitis With Nasal Polyps
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CM310
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps
Eligibility Criteria
Inclusion Criteria:
- The patient must be able to understand and voluntarily sign an ICF.
Participated in the clinical study of CM310 in patients with CRSwNP (Study No. of CM310NP001) and meet the criterion "a" or "b" as below:
- Patients have completed the treatment as required by the protocol and completed the EOS (V12) visit;
- Early withdrawal from the visit due to poor compliance or other objective reasons other than CM310-related AE, and the patient have completed early withdraw visit as per protocol, and, as assessed by the investigator and sponsor, the factors resulting in early termination of main study treatment have disappeared/will not affect the patient's participation in this extension study.
- Patients must have received INCS at a relatively stable dose for at least 4 weeks upon the screening visit.
Exclusion Criteria:
- Patients who are considered ineligible for continuous CM310 treatment by the investigator and the sponsor due to CM310-related* SAE or discontinuation caused by CM310-related* AE developed in the main study.
- Patients who had poor compliance in the main study and are judged unable to complete this study by the investigator.
- Not enough washing-out period for previous therapy.
- Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
- Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN) or serum creatinine level > ULN.
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Sites / Locations
- Beijing Tong-Ren hospitalRecruiting
- Site 3
- Site 2
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CM310
Arm Description
Outcomes
Primary Outcome Measures
Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
Secondary Outcome Measures
Changes from baseline in total nasal polyp score (NPS) from both sides at each evaluation time point.
The NPS score will be graded based on the nasal polyp size of both left and right nostrils described by nasal endoscopy by the study doctor nasal endoscopy. Each nostril is scored on a scale of 0-4, with the total score being the sum of both nostrils (0-8).
Changes from baseline in weekly average nasal congestion score (NCS) at each evaluation time point.
The NCS scoring ranges from 0-3 points and is conducted separately on both left and right nostril. The higher score from either left or right side is taken as the NCS score on each day, and the total score is 3 points.
Changes from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at each evaluation time point.
The UPSIT has a total of 40 questions and consists of 4 different booklets. The test patient will smell the odorant level after cutting the capsule with a nail or pencil and then choose an answer from 4 choices on each page. One score is counted if an odor is correctly selected, with a total score of 40 points. The lower the score, the more impaired the smell function.
Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point.
The SNOT-22 score is a specific scale for chronic rhinosinusitis and can evaluate the patient-reported outcome (PRO) and health-related quality of life (HRQoL) of patients suffering from chronic rhinosinusitis, with contents covering 22 dimensions related to quality of life. Each dimension is scored as 0-5, so with a total score of 110.
Changes from baseline in patient's nasal total symptom score (TSS) at each evaluation timepoint.
The evaluation content of TSS includes three aspects: nasal congestion, loss of smell and running nose. Each aspect has a score of 0-3 with a total score of 0-9. The higher score indicates the more severe overall symptom.
Changes from baseline in Lund-Mackay score of sinus CT scan at each evaluation time point.
Sinus CT scan evaluation includes Lund-Mackay scores and 3D volumetric measurement of the sinus, which are objective evaluation parameters commonly used to evaluate the severity of CRS.
Changes from baseline in three-dimensional sinus inflammation volume of sinus CT scan performed sat each evaluation time point.
Sinus CT scan evaluation includes Lund-Mackay scores and 3D volumetric measurement of the sinus, which are objective evaluation parameters commonly used to evaluate the severity of CRS.
Changes from baseline in total scores of NPS and NCS in patients with a nasal polyp surgery history or complication with asthma at each evaluation time point.
Percentage of patients receiving rescue therapy.
Immunogenicity endpoint: generation of anti-drug antibodies (ADAs) and/or neutralizing antibodies (Nabs).
PD endpoint: Changes from baseline in eosinophils levels in plasma and nasal polyp biopsy samples at each evaluation time point.
PK endpoint: steady-state trough concentration (CtroughSS) of CM310.
Full Information
NCT ID
NCT05131464
First Posted
November 11, 2021
Last Updated
December 9, 2021
Sponsor
Keymed Biosciences Co.Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05131464
Brief Title
The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps
Official Title
An Open-label, Single-arm, Multicenter, Extension Study to Evaluate the Long-term Safety and Efficacy of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keymed Biosciences 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 is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of CM310 in patients with CRSwNP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis With Nasal Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CM310
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CM310
Intervention Description
CM310, 300 mg/2 mL, SC, every 2 weeks
Primary Outcome Measure Information:
Title
Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
Description
Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
Time Frame
approximately 2 years
Secondary Outcome Measure Information:
Title
Changes from baseline in total nasal polyp score (NPS) from both sides at each evaluation time point.
Description
The NPS score will be graded based on the nasal polyp size of both left and right nostrils described by nasal endoscopy by the study doctor nasal endoscopy. Each nostril is scored on a scale of 0-4, with the total score being the sum of both nostrils (0-8).
Time Frame
approximately 2 years
Title
Changes from baseline in weekly average nasal congestion score (NCS) at each evaluation time point.
Description
The NCS scoring ranges from 0-3 points and is conducted separately on both left and right nostril. The higher score from either left or right side is taken as the NCS score on each day, and the total score is 3 points.
Time Frame
approximately 2 years
Title
Changes from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at each evaluation time point.
Description
The UPSIT has a total of 40 questions and consists of 4 different booklets. The test patient will smell the odorant level after cutting the capsule with a nail or pencil and then choose an answer from 4 choices on each page. One score is counted if an odor is correctly selected, with a total score of 40 points. The lower the score, the more impaired the smell function.
Time Frame
approximately 2 years
Title
Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point.
Description
The SNOT-22 score is a specific scale for chronic rhinosinusitis and can evaluate the patient-reported outcome (PRO) and health-related quality of life (HRQoL) of patients suffering from chronic rhinosinusitis, with contents covering 22 dimensions related to quality of life. Each dimension is scored as 0-5, so with a total score of 110.
Time Frame
approximately 2 years
Title
Changes from baseline in patient's nasal total symptom score (TSS) at each evaluation timepoint.
Description
The evaluation content of TSS includes three aspects: nasal congestion, loss of smell and running nose. Each aspect has a score of 0-3 with a total score of 0-9. The higher score indicates the more severe overall symptom.
Time Frame
approximately 2 years
Title
Changes from baseline in Lund-Mackay score of sinus CT scan at each evaluation time point.
Description
Sinus CT scan evaluation includes Lund-Mackay scores and 3D volumetric measurement of the sinus, which are objective evaluation parameters commonly used to evaluate the severity of CRS.
Time Frame
approximately 2 years
Title
Changes from baseline in three-dimensional sinus inflammation volume of sinus CT scan performed sat each evaluation time point.
Description
Sinus CT scan evaluation includes Lund-Mackay scores and 3D volumetric measurement of the sinus, which are objective evaluation parameters commonly used to evaluate the severity of CRS.
Time Frame
approximately 2 years
Title
Changes from baseline in total scores of NPS and NCS in patients with a nasal polyp surgery history or complication with asthma at each evaluation time point.
Time Frame
approximately 2 years
Title
Percentage of patients receiving rescue therapy.
Time Frame
approximately 2 years
Title
Immunogenicity endpoint: generation of anti-drug antibodies (ADAs) and/or neutralizing antibodies (Nabs).
Time Frame
approximately 2 years
Title
PD endpoint: Changes from baseline in eosinophils levels in plasma and nasal polyp biopsy samples at each evaluation time point.
Time Frame
approximately 2 years
Title
PK endpoint: steady-state trough concentration (CtroughSS) of CM310.
Time Frame
approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must be able to understand and voluntarily sign an ICF.
Participated in the clinical study of CM310 in patients with CRSwNP (Study No. of CM310NP001) and meet the criterion "a" or "b" as below:
Patients have completed the treatment as required by the protocol and completed the EOS (V12) visit;
Early withdrawal from the visit due to poor compliance or other objective reasons other than CM310-related AE, and the patient have completed early withdraw visit as per protocol, and, as assessed by the investigator and sponsor, the factors resulting in early termination of main study treatment have disappeared/will not affect the patient's participation in this extension study.
Patients must have received INCS at a relatively stable dose for at least 4 weeks upon the screening visit.
Exclusion Criteria:
Patients who are considered ineligible for continuous CM310 treatment by the investigator and the sponsor due to CM310-related* SAE or discontinuation caused by CM310-related* AE developed in the main study.
Patients who had poor compliance in the main study and are judged unable to complete this study by the investigator.
Not enough washing-out period for previous therapy.
Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN) or serum creatinine level > ULN.
Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Facility Information:
Facility Name
Beijing Tong-Ren hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luo Zhang
Phone
13910830399
Email
dr.luozhang@139.com
Facility Name
Site 3
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site 2
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Learn more about this trial
The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps
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