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NOT YET RECRUITING
NCT07755371
PHASE2

A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps

Sponsor: Akeso

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection compared with placebo in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) receiving background treatment with mometasone furoate nasal spray (MFNS).

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study Evaluating the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-08-10

Completion Date

2027-07-31

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

AK139

AK139 administered subcutaneously

BIOLOGICAL

Placebo

Placebo administered subcutaneously

Locations (1)

Eye & ENT Hospital of Fudan University

Shanghai, China