The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps

NCT ID: NCT05131464

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2024-01-31

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CM310

Group Type: EXPERIMENTAL

CM310

Intervention Type: DRUG

CM310, 300 mg/2 mL, SC, every 2 weeks

Interventions

CM310

CM310, 300 mg/2 mL, SC, every 2 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tong-Ren hospital

Beijing, , China

Site 3

Chengdu, , China

Site 2

Wuhan, , China

Countries

China

Other Identifiers

CM310NP100

Identifier Type: -

Identifier Source: org_study_id