This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps.
The study consists of 3 periods, a Screening Period, a Treatment Period and a Safety Follow-up Period. Subjects who meet eligibility criteria will be randomized to receive either CM326 or placebo subcutaneously.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: up to Week 64
Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 16.
NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Time frame: at week 16
PK: Concentration of CM326 in plasma
Concentration of CM326 in plasma
Time frame: up to Week 64
Immunogenicity: anti-drug antibody (ADA)
Occurrence of positive anti-drug antibody (ADA)
Time frame: up to Week 64
PD: Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration.
Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration.
Time frame: up to Week 64
PD: Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration.
Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration.
Time frame: up to Week 64
PD: Changes from baseline in plasma interleukin-5 (IL-5) after CM326 administration
Changes from baseline in plasma interleukin-5 (IL-5) after CM326 administration
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Time frame: up to Week 64
PD: Changes from baseline in plasma interleukin-13 (IL-13) after CM326 administration
Changes from baseline in plasma interleukin-13 (IL-13) after CM326 administration
Time frame: up to Week 64
PD: Changes from baseline in serum periostin after CM326 administration
Changes from baseline in serum periostin after CM326 administration
Time frame: up to Week 64
PD: Changes from baseline in blood eosinophilic level after CM326 administration
Changes from baseline in blood eosinophil level after CM326 administration
Time frame: up to Week 64
PD: Changes from baseline in eosinophilic level of nasal polyp biopsy tissue after CM326 administration
Changes from baseline in eosinophil level of Nasal polyp biopsy tissue after CM326 administration
Time frame: up to Week 64
Efficacy: changes from baseline of nasal polyp score (NPS) in non-eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP)
NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Time frame: up to Week 64