Chronic Rhinosinusitis With Nasal Polyposis
Conditions
Brief summary
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).
Detailed description
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).
Interventions
BIOLOGICALCM512
Administered subcutaneous injection
DRUGPlacebo
Administered subcutaneous injection
Sponsors
Beijing Keymed Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* with chronic rhinosinusitis with nasal polyposis (CRSwNP). * Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity. * Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline. * Contraception.
Exclusion criteria
* Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity. * Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Polyps Score (NPS) | at week 24 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in NPS at other visits | baseline up to week 36 |
| Change from baseline in Nasal Congestion Score (NCS) at each visit | baseline up to week 36 |
| Proportion of participants achieving an improvement in NPS from baseline of ≥ 1 point and ≥ 2 points at each visit | baseline up to week 36 |
| Change from baseline in Total Symptom Score (TSS) at each visit | baseline up to week 36 |
| Change from baseline in Loss of Smell (LoS) score at each visit | baseline up to week 36 |
| Change from baseline in Lund-Mackay (LMK) score evaluated by sinus computed tomography (CT) at each visit | baseline up to week 36 |
| Change from baseline in 22-item Sino-nasal Outcome Test (SNOT-22) score at each visit | baseline up to week 36 |
| Incidence of treatment-emergent adverse events (TEAEs) | baseline up to week 36 |
| physical examination | baseline up to week 36 |
| vital signs | baseline up to week 36 |
| 12-lead electrocardiogram (ECG) | baseline up to week 36 |
| clinical laboratory tests | baseline up to week 36 |
| Concentration of CM512 in serum | baseline up to week 36 |
| Change from baseline and percent change from baseline in serum total immunoglobulin E (IgE) level at each visit | baseline up to week 36 |
| Change from baseline and percent change from baseline in peripheral blood eosinophil (EOS) level at each visit | baseline up to week 36 |
| Change from baseline and percent change from baseline in serum interleukin-5 (IL-5) level at each visit | baseline up to week 36 |
| Change from baseline and percent change from baseline in serum interleukin-13 (IL-13) level at each visit | baseline up to week 36 |
| Change from baseline and percent change from baseline in serum thymic stromal lymphopoietin (TSLP) level at each visit | 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 | baseline up to week 36 |
| Change from baseline and percent change from baseline in serum eotaxin-3 level at each visit | baseline up to week 36 |
| Change from baseline and percent change from baseline in serum chemokine 13 (CCL13) level at each visit | baseline up to week 36 |
| Change from baseline and percent change from baseline in serum chemokine 22 (CCL22) level at each visit | baseline up to week 36 |
| Change from baseline and percent change from baseline in serum periostin level at each visit. | baseline up to week 36 |
| Change from baseline and percent change from baseline in EOS levels in nasal polyp biopsy tissue | baseline up to week 24 |
| Incidence of Anti-drug antibodies (ADA) | baseline up to week 36 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLuo Zhang
Beijing Tong-Ren hospital
Outcome results
None listed