Status:
COMPLETED
Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1)
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Nasal Polyps
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 tre...
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...
Eligibility Criteria
Inclusion
- Bilateral CRSwNP.
- Prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps.
- Stable dose of intranasal corticosteroids for at least 4 weeks before screening.
- Ongoing symptoms for at least 4 weeks before screening：1)Nasal congestion/obstruction; 2)Othe symptom, e.g., loss of smell or rhinorrhea.
- Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.
- NCS score of 2 or 3 at screening and at baseline.
- Eosinophilic level meets the one of the following criteria: 1) serum eosinophil count ≥6.9% (without concomitant asthma) or ≥3.7% (with concomitant asthma) at screening; 2) absolute count of ≥55 per high power field or percentage of ≥27% in eosinophil level from nasal polyps biospy tissue.
- Contraception.
Exclusion
- Not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for IL-4Rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).
- concurrent disease, e.g., ongoing rhinitis medicamentosa, acute sinusitis, nasal infection or upper respiratory infection, allergic fungal rhinosinusitis, malignancy, uncontrolled chronic disease such as cardivascular diseases, tuberculosis, diabetes etc.
- Allergic or intolerant to mometasone furoate spray or CM310/placebo.
- Significant liver or renal dysfunction.
- Other.
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04805398
Start Date
April 6 2021
End Date
March 18 2022
Last Update
June 29 2022
Active Locations (19)
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1
Beijing Chaoyang Hospital, CMU
Beijing, Beijing Municipality, China
2
Beijing Hospital
Beijing, Beijing Municipality, China
3
Beijing Renmin Hospital
Beijing, Beijing Municipality, China
4
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China