A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps.

The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week Treatment Period and a 12-week Safety Follow-up Period.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keymed Biosciences Co.Ltd

Criteria

Inclusion Criteria:

• Diagnosed with Chronic Rhinosinusitis With Nasal Polyps at least 12 months before the screening.

• Prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps.

• Ongoing symptoms for at least 4 weeks before screening：1) Nasal congestion/obstruction; 2) Other symptom, e.g., loss of smell or rhinorrhea.

Exclusion Criteria:

• Allergic or intolerant to mometasone furoate spray or CM326/placebo.

• Not enough washing-out 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 systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).

• concurrent disease, e.g., acute sinusitis, nasal infection, or upper respiratory infection etc.