NCT06706817

A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab

A Multicentre, Single-Arm, Phase 3b Study to Assess Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab (ESSENCE)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate treatment outcomes of tezepelumab among participants with physician-determined surgery-eligible CRSwNP, with or without asthma. Study details include: 1. The study duration will be up to 40 weeks. 2. The treatment duration will be up to 24 weeks. 3. The visit frequency will be once every 4 weeks (Q4W).

Detailed description

This is a multicentre, open-label, single-arm, phase IIIb study is to describe changes from baseline in (1) participant-reported nasal congestion as evaluated by the nasal congestion score (NCS) and (2) participant-reported sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) following initiation of tezepelumab treatment. Approximately 60 sites in 10 countries will enrol adult patients with physician determined surgery eligible CRSwNP. The study is divided into 3 periods as described below: * Screening Period (from Week -4 until Week 0, up to 4 Weeks) * Treatment period (Week 0 to Week 24) * Safety Follow-up Period (Week 24 to Week 36)

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tezepelumab	IMP. Subcutaneous injection. Unit dose strengths 210 mg.

Timeline

• Start date: 2024-12-03
• Primary completion: 2027-01-13
• Completion: 2027-01-13
• First posted: 2024-11-27
• Last updated: 2026-03-20

Locations

44 sites across 9 countries: United States, Bulgaria, Canada, France, Germany, Hungary, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study
• FDA-regulated device study