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

NCT04805398 | Completed Phase 2

• 1 other identifier: CM310NP001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 19

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).

Conditions

Chronic Rhinosinusitis (Diagnosis); Nasal Polyps

Keywords

Chronic Rhinosinusitis with Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• Bilateral endoscopic Nasal Polyps Score (NPS)

  Change from baseline in the bilateral endoscopic NPS.NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.

  at Week 16

• Nasal Congestion/Obstruction SymptomSeverity (NCS) Score

  Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.

  at Week 16

Secondary Outcomes (16)

• Time to the first response of NPS

  Baseline up to Week 24

• Lund-Mackay score

  at Week 16

• Volume of the involved area of nasosinusitis on 3D-construction CT scan

  at Week 16

• Bilateral endoscopic NPS

  at Week 8

• Proportion of subjects receiving rescue therapy for nasal polyps

  Baseline up to Week 24

Study Arms (2)

CM310

EXPERIMENTAL

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

Biological: CM310

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

CM310 BIOLOGICAL

300 mg every two weeks

CM310

Placebo BIOLOGICAL

300 mg every two weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (19)

Beijing Chaoyang Hospital, CMU

Beijing, Beijing Municipality, China

Location

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Beijing Renmin Hospital

Beijing, Beijing Municipality, China

Location

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Location

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

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

Wuhan, Hubei, China

Location

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Location

Shandong Second Provincial General Hospital (Shandong ENT hospital)

Jinan, Shangdong, China

Location

Renji Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 37483544 DERIVED

MeSH Terms

Conditions

Disease; Nasal Polyps

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical

Study Officials

• Luo Zhang

  Beijing Tongren Hospital, CMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 18, 2021
• Study Start: April 6, 2021
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: June 29, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (19)