This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period) and Safety Follow-up Period (12 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Beijing Tong-Ren hospital
Beijing, China
Nasal Polyps Score (NPS)
Change from baseline in the Nasal Polyps Score (NPS) at week 24. 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 24
Change from baseline in NPS at other visits
Time frame: baseline up to week 36
Change from baseline in Nasal Congestion Score (NCS) at each visit
Time frame: baseline up to week 36
Proportion of participants achieving an improvement in NPS from baseline of ≥ 1 point and ≥ 2 points at each visit
Time frame: baseline up to week 36
Change from baseline in Total Symptom Score (TSS) at each visit
Time frame: baseline up to week 36
Change from baseline in Loss of Smell (LoS) score at each visit
Time frame: baseline up to week 36
Change from baseline in Lund-Mackay (LMK) score evaluated by sinus computed tomography (CT) at each visit
Time frame: baseline up to week 36
Change from baseline in 22-item Sino-nasal Outcome Test (SNOT-22) score at each visit
Time frame: baseline up to week 36
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: baseline up to week 36
physical examination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: baseline up to week 36
vital signs
Time frame: baseline up to week 36
12-lead electrocardiogram (ECG)
Time frame: baseline up to week 36
clinical laboratory tests
Time frame: baseline up to week 36
Concentration of CM512 in serum
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum total immunoglobulin E (IgE) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in peripheral blood eosinophil (EOS) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum interleukin-5 (IL-5) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum interleukin-13 (IL-13) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum thymic stromal lymphopoietin (TSLP) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum thymus and activation-regulated chemokine (TARC) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum eotaxin-3 level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum chemokine 13 (CCL13) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum chemokine 22 (CCL22) level at each visit
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in serum periostin level at each visit.
Time frame: baseline up to week 36
Change from baseline and percent change from baseline in EOS levels in nasal polyp biopsy tissue
Time frame: baseline up to week 24
Incidence of Anti-drug antibodies (ADA)
Time frame: baseline up to week 36