Trials / Completed
CompletedNCT04805398
Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1)
A Randomized, Double Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety, PK, PD and Immunogenicity of Subcutaneously Given Multiple-Dose CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Keymed Biosciences Co.Ltd · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of CM310 in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
Detailed description
The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks, till End-of-Treatment Visit) and a Safety Follow-up Period (8 weeks, till End-of-Study Visit). 56 patients who meet eligibility criteria will be randomized 1:1 to receive either CM310 300mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All patients will receive MFNS on a daily basis as a background treatment throughout the study. MFNS is required to use no less than 14 days during Screening/run-in Period. Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CM310 | 300 mg every two weeks |
| BIOLOGICAL | Placebo | 300 mg every two weeks |
Timeline
- Start date
- 2021-04-06
- Primary completion
- 2022-03-18
- Completion
- 2022-03-18
- First posted
- 2021-03-18
- Last updated
- 2022-06-29
Locations
19 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04805398. Inclusion in this directory is not an endorsement.