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

NCT06706817 | Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: D5242C00002
• Study Type: interventional
• Target: 180
• Locations: 9 countries
• Sites: 45

Brief 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. 1.The study duration will be up to 40 weeks.
2. 2.The treatment duration will be up to 24 weeks.
3. 3.The visit frequency will be once every 4 weeks (Q4W).

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

Chronic rhinosinusitis; Rhinosinusitis

Outcome Measures

Primary Outcomes (2)

• Change from baseline in nasal congestion

  Changes from baseline in participant-reported nasal congestion as evaluated by the nasal congestion score (NCS) as part of the nasal polyposis symptom diary (NPSD) following initiation of tezepelumab treatment.

  Week 24

• Change from baseline in sino-nasal symptoms

  changes from baseline in participant reported sino nasal symptoms as evaluated by sino nasal outcome test, 22 item (SNOT 22) total score following initiation of tezepelumab treatment.

  Week 24

Secondary Outcomes (44)

• Proportion of NCS responders

  End of treatment - Week 24

• Time to first response for NCS

  End of Treatment-week 24

• Change from baseline in NCS

  Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24).

• Proportion of SNOT-22 responders

  Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.

• Time to first response for SNOT-22

  Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.

Other Outcomes (23)

• Endoscopy findings will be used to describe histological changes and describe CRSwNP visualization

  Screening, Weeks 2 and 24

• Change from baseline in blood eosinophil count (BEC), total serum IgE, specific IgE (including fungi/moulds [eg, Alternaria]), S. aureus enterotoxin IgE, and Fractional exhaled nitric oxide (FeNO; for asthma participants only)

  Screening (for BEC and FeNO), Week 0 (for IgE and S. aureus enterotoxin IgE), Weeks 12 and 24

• Change from baseline in WPAI-CRSwNP

  Week 0 and Week 24

Study Arms (1)

Tezepelumab

EXPERIMENTAL

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Combination Product: Tezepelumab

Interventions

Tezepelumab COMBINATION_PRODUCT

IMP. Subcutaneous injection. Unit dose strengths 210 mg.

Also known as: TEZSPIRE®

Tezepelumab

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18 years of age or older, at the time of signing the informed consent.
• Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following:
• Severity consistent with the need for surgery as defined by total NPS ≥ 4 (at least 2 for each nostril) at screening, as determined by the central reader
• Mean NCS ≥ 2 in the 2 weeks prior to Visit 2
• Ongoing documented NP symptoms for \> 8 weeks prior to screening such as rhinorrhoea, reduction or loss of smell and/or poor quality/loss of sleep
• SNOT-22 total score ≥ 30 as assessed at screening. Note: approximately 50 participants with a NPS = 4 at screening will receive treatment with tezepelumab.
• Any standard of care for treatment of CRSwNP, which must include treatment with intranasal corticosteroids, provided the participant is stable on that treatment for at least 30 days prior to Visit 1. Investigators should also assure that participants are compliant and on a stable dose of the background INCS during study period.
• Either 1) documented treatment of NP exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance to) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 OR 2) any history of NP surgery (or contraindications/intolerance to)
• Body weight of ≥ 40 kg at Visit 1
• Female participants:
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of non childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
• Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned start date of the first IMP administration without an alternative medical cause.
• The following age-specific requirements apply:
• Women \< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range.
• Women ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.

You may not qualify if:

• Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.
• Any clinically important pulmonary disease other than asthma (eg, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc) that could confound interpretation of clinical CRSwNP endpoints results.
• Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
• Affect the safety of the participant throughout the study
• Influence the findings of the study or the interpretation
• Impede the participant's ability to complete the entire duration of study.
• Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible.
• Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:
• Antrochoanal polyps
• Nasal septal deviation that occludes at least one nostril
• Acute sinusitis, nasal infection, asthma exacerbation or upper respiratory infection at screening or in the two weeks before screening, or Churg-Strauss syndrome (also known as eosinophilic granulomatosis with polyangiitis), Young's syndrome or Kartagener's syndrome
• History of cancer:
• Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1.
• Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.
• Uncontrolled epistaxis within 2 months of Visit 1

Sponsors & Collaborators

• AstraZeneca: lead
• Fortrea: collaborator

Study Sites (45)

Research Site

Newport Beach, California, 92663, United States

RECRUITING

Research Site

Chicago, Illinois, 60611, United States

RECRUITING

Research Site

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

Research Site

Columbia, Missouri, 65201, United States

RECRUITING

Research Site

Plovdiv, 4003, Bulgaria

RECRUITING

Research Site

Sofia, 1431, Bulgaria

RECRUITING

Research Site

Sofia, 1606, Bulgaria

WITHDRAWN

Research Site

Sofia, 1606, Bulgaria

RECRUITING

Research Site

Hamilton, Ontario, L8S 1G5, Canada

RECRUITING

Research Site

Québec, Quebec, G1L 3L5, Canada

RECRUITING

Research Site

Québec, Quebec, G1V 4W2, Canada

RECRUITING

Research Site

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Research Site

Lille, 59000, France

WITHDRAWN

Research Site

Marseille, 13005, France

RECRUITING

Research Site

Nantes, 44093, France

RECRUITING

Research Site

Pierre-Bénite, 69495, France

RECRUITING

Research Site

Poitiers, 86000, France

RECRUITING

Research Site

Toulouse, 31400, France

RECRUITING

Research Site

Düsseldorf, 40225, Germany

WITHDRAWN

Research Site

Marburg, 35043, Germany

RECRUITING

Research Site

Tübingen, 72076, Germany

RECRUITING

Research Site

Villingen-Schwenningen, 78052, Germany

RECRUITING

Research Site

Wiesbaden, 65183, Germany

RECRUITING

Research Site

Budapest, 1085, Hungary

RECRUITING

Research Site

Budapest, 1134, Hungary

RECRUITING

Research Site

Nyíregyháza, 4400, Hungary

RECRUITING

Research Site

Pécs, 7621, Hungary

RECRUITING

Research Site

Bologna, 40139, Italy

RECRUITING

Research Site

Catania, 95123, Italy

RECRUITING

Research Site

Florence, 50139, Italy

RECRUITING

Research Site

Naples, 80131, Italy

WITHDRAWN

Research Site

Padua, 35128, Italy

RECRUITING

Research Site

Pisa, 56126, Italy

RECRUITING

Research Site

Roma, 00168, Italy

RECRUITING

Research Site

Rozzano, 20089, Italy

RECRUITING

Research Site

Bialystok, 15-879, Poland

RECRUITING

Research Site

Bydgoszcz, 85-231, Poland

RECRUITING

Research Site

Lodz, 90-302, Poland

RECRUITING

Research Site

Zawadzkie, 47-120, Poland

RECRUITING

Research Site

Barcelona, 08003, Spain

RECRUITING

Research Site

Barcelona, 08035, Spain

RECRUITING

Research Site

Cadiz, 11011, Spain

RECRUITING

Research Site

Madrid, 28041, Spain

RECRUITING

Research Site

Salamanca, 37007, Spain

RECRUITING

Research Site

Santiago de Compostela, 15706, Spain

RECRUITING

MeSH Terms

Conditions

Rhinosinusitis

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Tanya M Laidlaw, MD

  Director of Translational Research in Allergy and Director of the Aspirin-Exacerbated Respiratory Disease (AERD) Centre at the Brigham and Women's Hospital.

  PRINCIPAL INVESTIGATOR

• Enrico Heffler, MD, PhD

  Associate Professor of Internal Medicine and Consultant at the Personalized Medicine, Asthma and Allergy Unit at IRCCS Humanitas Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, single-arm treatment study. Participants will be treated with tezepelumab Q4W from Week 0, with the last dose administered at Week 20

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 27, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

ES (6); DE (5); BU (4); IT (8); PL (4); US (4); HU (4); CA (3); FR (7)