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

NCT07755371 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-08-10

No results posted yet for this study

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).

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

BIOLOGICAL

AK139

AK139 administered subcutaneously

BIOLOGICAL

Placebo

Placebo administered subcutaneously

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2027-04-30
Completion
2027-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755371 on ClinicalTrials.gov