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

NCT05131464 | Completed Phase 2

• 1 other identifier: CM310NP100
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 2 years

Secondary Outcomes (12)

• Changes from baseline in total nasal polyp score (NPS) from both sides at each evaluation time point.

  approximately 2 years

• Changes from baseline in weekly average nasal congestion score (NCS) at each evaluation time point.

  approximately 2 years

• Changes from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at each evaluation time point.

  approximately 2 years

• Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point.

  approximately 2 years

• Changes from baseline in patient's nasal total symptom score (TSS) at each evaluation timepoint.

  approximately 2 years

Study Arms (1)

CM310

EXPERIMENTAL

Drug: CM310

Interventions

CM310 DRUG

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

CM310

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (3)

Beijing Tong-Ren hospital

Beijing, China

Location

Site 3

Chengdu, China

Location

Site 2

Wuhan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: November 30, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: November 8, 2024

Record last verified: 2023-12

Locations

CN (3)