Chronic Rhinosinusitis With Nasal PolypsPhase 2NCT05131464
The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps
A Phase 2 study testing CM310 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Keymed Biosciences Co.Ltd at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- CM310
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesChina
- Study dates
- 30 Nov 2021to 31 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
About this study
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
This is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of CM310 in patients with CRSwNP.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- CM310
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM310Drug
CM310, 300 mg/2 mL, SC, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| CM310 | Experimental | Not described Receives: Drug: CM310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 2 years
Secondary outcomes (12)
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).
Measured: approximately 2 years
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.
Measured: approximately 2 years
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.
Measured: approximately 2 years
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.
Measured: approximately 2 years
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.
Measured: approximately 2 years
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.
Measured: approximately 2 years
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.
Measured: approximately 2 years
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.
Measured: approximately 2 years
Percentage of patients receiving rescue therapy.
Measured: approximately 2 years
Immunogenicity endpoint: generation of anti-drug antibodies (ADAs) and/or neutralizing antibodies (Nabs).
Measured: approximately 2 years
PD endpoint: Changes from baseline in eosinophils levels in plasma and nasal polyp biopsy samples at each evaluation time point.
Measured: approximately 2 years
PK endpoint: steady-state trough concentration (CtroughSS) of CM310.
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start30 Nov 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131464
- Sponsor's protocol ID
- CM310NP100
- Status last verified
- Dec 2023
- First submitted
- 11 Nov 2021
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05131464
- Acronym / sponsor ID
- CM310NP100
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Nov 2021 (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 is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of CM310 in patients with CRSwNP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM310 | Experimental | Drug: CM310 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 must have received INCS at a relatively stable dose for at least 4 weeks upon the screening visit.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| CM310CM310, 300 mg/2 mL, SC, every 2 weeks | Drug | CM310 |
Primary outcome
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
Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
12 secondary outcomes
Changes from baseline in total nasal polyp score (NPS) from both sides at each evaluation time point.
Time frame: approximately 2 years
Changes from baseline in weekly average nasal congestion score (NCS) at each evaluation time point.
Time frame: approximately 2 years
Changes from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at each evaluation time point.
Time frame: approximately 2 years
Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point.
Time frame: approximately 2 years
Changes from baseline in patient's nasal total symptom score (TSS) at each evaluation timepoint.
Time frame: approximately 2 years
Changes from baseline in Lund-Mackay score of sinus CT scan at each evaluation time point.
Time frame: approximately 2 years
Changes from baseline in three-dimensional sinus inflammation volume of sinus CT scan performed sat each evaluation time point.
Time frame: approximately 2 years
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
Percentage of patients receiving rescue therapy.
Time frame: approximately 2 years
Immunogenicity endpoint: generation of anti-drug antibodies (ADAs) and/or neutralizing antibodies (Nabs).
Time frame: approximately 2 years
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
PK endpoint: steady-state trough concentration (CtroughSS) of CM310.
Time frame: approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM310 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Keymed Biosciences Co.Ltd at 3 sites 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 8 Nov 2024.