A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）

NCT05436275 | Completed Phase 3

• 1 other identifier: CM310-102208
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM310, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM310 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Conditions

Chronic Rhinosinusitis With Nasal Polyposis

Outcome Measures

Primary Outcomes (2)

• Nasal Polyps Score (NPS)

  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.

  at week 24

• Nasal Congestion Score (NCS)

  Change from baseline in the Nasal Congestion Score (NCS) at week 24. NCS score range from 0 to 3, with higher score means worse nasal symptom.

  at week 24

Secondary Outcomes (4)

• Safety parameters

  Baseline up to Week 60

• Pharmacokinetics (PK)

  Baseline up to Week 60

• Pharmacodynamics (PD)

  Baseline up to Week 60

• Anti-drug antibodies (ADA)

  Baseline up to Week 60

Study Arms (2)

CM310

EXPERIMENTAL

CM310 300mg is given subcutaneously (SC) every two weeks

Biological: Placebo

Placebo

PLACEBO COMPARATOR

Placebo is given subcutaneously (SC) every two weeks

Biological: CM310

Interventions

CM310 BIOLOGICAL

300 mg every two weeks

Placebo

Placebo BIOLOGICAL

once every two weeks

CM310

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with chronic rhinosinusitis with nasal polyposis (CRSwNP).
• Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
• NCS score of 2 or 3 at screening period, and at least 2 at baseline.
• 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).
• Participated and any studies of CM310.
• With malignant or benign tumor of nasal cavity.
• Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Location

Related Publications (2)

• Shen S, Yan B, Wang M, Wu D, Piao Y, Tang J, Yang X, Cao Z, Xue J, Liu W, Liu S, Shi L, Wang G, Song X, Lu Y, Chen J, Jiang L, Ye J, Yu S, Yang Y, Fang H, Li J, Shi H, Fan J, Yan H, Wang H, Chen B, Wang C, Zhang L; CROWNS-2 Study Investigators. Stapokibart for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps: The CROWNS-2 Randomized Clinical Trial. JAMA. 2025 Aug 18;334(11):962-72. doi: 10.1001/jama.2025.12515. Online ahead of print.

  PMID: 40824573 DERIVED

• Shen S, Yan B, Wang M, Wu D, Wang C, Zhang L. Anti-IL-4Ralpha monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Asia Pac Allergy. 2024 Aug;14(3):118-123. doi: 10.5415/apallergy.0000000000000156. Epub 2024 Aug 5.

  PMID: 39220573 DERIVED

Study Officials

• Luo Zhang

  Beijing Tong-Ren hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 20, 2022
• First Posted: June 29, 2022
• Study Start: August 9, 2022
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-06

Locations

CN (1)