Clinical trial NCT05131464: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

  1. Patients have completed the treatment as required by the protocol and completed the EOS (V12) visit;
  2. 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.

Primary outcomes:
measure: Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
timeFrame: approximately 2 years
Secondary outcomes:
measure: Changes from baseline in total nasal polyp score (NPS) from both sides at each evaluation time point.
timeFrame: approximately 2 years
measure: Changes from baseline in weekly average nasal congestion score (NCS) at each evaluation time point.
timeFrame: approximately 2 years
measure: Changes from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at each evaluation time point.
timeFrame: approximately 2 years
measure: Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point.
timeFrame: approximately 2 years
measure: Changes from baseline in patient's nasal total symptom score (TSS) at each evaluation timepoint.
timeFrame: approximately 2 years
measure: Changes from baseline in Lund-Mackay score of sinus CT scan at each evaluation time point.
timeFrame: approximately 2 years
measure: Changes from baseline in three-dimensional sinus inflammation volume of sinus CT scan performed sat each evaluation time point.
timeFrame: approximately 2 years
measure: 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.
timeFrame: approximately 2 years
measure: Percentage of patients receiving rescue therapy.
timeFrame: approximately 2 years
measure: Immunogenicity endpoint: generation of anti-drug antibodies (ADAs) and/or neutralizing antibodies (Nabs).
timeFrame: approximately 2 years
measure: PD endpoint: Changes from baseline in eosinophils levels in plasma and nasal polyp biopsy samples at each evaluation time point.
timeFrame: approximately 2 years
measure: PK endpoint: steady-state trough concentration (CtroughSS) of CM310.
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tong-Ren hospital
city: Chengdu
country: China
facility: Site 3
city: Wuhan
country: China
facility: Site 2
Study officials:
References: