Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1)

NCT ID: NCT04805398

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2022-03-18

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 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

Chronic Rhinosinusitis (Diagnosis); Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CM310

CM310 300mg is given subcutaneously (SC) every two weeks for 16-week treatment

Group Type: EXPERIMENTAL

CM310

Intervention Type: BIOLOGICAL

300 mg every two weeks

Placebo

Placebo is given subcutaneously (SC) every two weeks for 16-week treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

300 mg every two weeks

Interventions

CM310

300 mg every two weeks

Intervention Type: BIOLOGICAL

Placebo

300 mg every two weeks

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luo Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital, CMU

Locations

Beijing Chaoyang Hospital, CMU

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Beijing Renmin Hospital

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Jingzhou Central Hospital

Jingzhou, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Shandong Second Provincial General Hospital (Shandong ENT hospital)

Jinan, Shangdong, China

Renji Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Countries

China

References

Zhang Y, Yan B, Shen S, Song X, Jiang Y, Shi L, Zhao C, Yang Y, Jiang L, Li J, Ye J, Liu J, Wan L, Yang Y, Chen J, Liu F, Su L, Xu Y, Tan G, Yu S, Zhang Y, Wang L, Liu S, Yan H, Liu W, Chen B, Wang C, Zhang L. Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial. EClinicalMedicine. 2023 Jul 5;61:102076. doi: 10.1016/j.eclinm.2023.102076. eCollection 2023 Jul.

Reference Type: DERIVED

PMID: 37483544 (View on PubMed)

Other Identifiers

CM310NP001

Identifier Type: -

Identifier Source: org_study_id