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A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

NCT06454240 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-04-28

No results posted yet for this study

Summary

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.

The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.

Conditions

Interventions

DRUG

lunsekimig

Pharmaceutical form:solution for injection-Route of administration:subcutaneous

DRUG

placebo

Pharmaceutical form:solution for injection-Route of administration:subcutaneous

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2026-01-29
Completion
2026-04-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT06454240 on ClinicalTrials.gov