Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis

NCT06372678 | Not Yet Recruiting Phase 2

• 1 other identifier: CM326-102102
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24.

  Up to week 24

Study Arms (3)

220 mg Group

EXPERIMENTAL

CM326 220 mg, subcutaneous (SC)

Biological: CM326

440 mg Group

EXPERIMENTAL

CM326 440 mg, subcutaneous (SC)

Biological: CM326

placebo

PLACEBO COMPARATOR

matched placebo, subcutaneous (SC)

Drug: Placebo

Interventions

CM326 BIOLOGICAL

CM326 injection

220 mg Group; 440 mg Group

Placebo DRUG

Placebo

placebo

Eligibility Criteria

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

You may qualify if:

• Male or female subjects, aged between 18 and 75 years old (inclusive).
• Subjects who are capable of understanding the nature of the study and voluntarily signing the Informed consent form (ICF).
• Prior treatment with systemic corticosteroids (SCS) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening.

You may not qualify if:

• Allergic or intolerant to mometasone furoate spray or CM326.
• Have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period.
• Participated study of CM326.
• Systemic immunosuppressive therapy for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to baseline (whichever is longer).
• Starting leukotriene receptor antagonist therapy within 4 weeks prior to baseline.
• With antrochoanal polyps.
• With severe deviation of the nasal septum occludes at least one nostril.
• With persistent rhinitis medicamentosas.
• With acute sinusitis, nasal infection, or upper respiratory tract infection at screening.
• Have symptoms or whose CT scan suggests allergic fungal sinusitis.
• With malignant or benign neoplasm of nasal cavities.
• With other uncontrolled serious diseases or recurrent chronic diseases.
• Have severe hepatic and renal impairment.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Location

Study Officials

• Luo Zhang

  Beijing Tong-Ren hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620; qianjia@keymedbio.com

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: April 15, 2024
• First Posted: April 18, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-03

Locations

CN (1)