A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Launched by ASTRAZENECA · Nov 22, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called tezepelumab to see how well it helps adults with a condition called chronic rhinosinusitis with nasal polyps (CRSwNP), which can cause symptoms like nasal congestion and loss of smell. The trial will last up to 40 weeks, and participants will receive the treatment for up to 24 weeks, with visits every four weeks to monitor their progress.
To join the study, participants must be at least 18 years old and have been diagnosed with CRSwNP for over a year. They should have symptoms severe enough that a doctor thinks surgery might be needed. Participants will also need to be stable on standard treatments for their condition. This trial is open to both men and women, and those interested should be willing to meet specific health criteria. It's important to note that while this study aims to improve understanding and treatment of CRSwNP, participants will be carefully monitored throughout, and their health will be prioritized.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- * WOCBP must be willing to use one of the methods of contraception described hereafter, from the time of signing the ICF throughout the study and 16 weeks after last tezepelumab administration:
- • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
- • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
- • Intrauterine device
- • Intrauterine hormone-releasing system
- • Bilateral tubal occlusion
- • Vasectomised partner (vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success)
- • Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
- • Cessation of contraception after this point should be discussed with a responsible physician.
- • Provision of signed and dated written ICF as described in Appendix A 3 prior to any mandatory study-specific procedures, sampling, and analyses.
- • Participant who is capable of giving signed informed consent as described in Appendix A 3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Exclusion Criteria:
- • 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:
- • 1. 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.
- • 2. 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
- • A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
- • For participants with comorbid asthma: Current smokers or participants with a smoking history ≥ 10 packs per year and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack per year and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
- • History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
- • Tuberculosis requiring treatment within the 12 months prior to Visit 1.
- • Major surgery within 8 weeks prior to Visit 1 or planned NP surgery or planned surgical procedures requiring general anaesthesia or inpatient status for more than 1 day during the conduct of the study.
- • History of known immunodeficiency disorder including a positive HIV test at Visit 1, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
- • Infection requiring systemic antibiotics within 14 days prior to Visit 1. Note: Participants with respiratory infections requiring antibiotics within 14 days prior to Visit 1 may extend their screening period to allow recovery and return no sooner than 14 days after completion of therapy.
- • Evidence of COVID-19 within 4 weeks prior to screening or ongoing clinically significant COVID-19 sequelae (eg, participants who have long-term post-COVID-19 anosmia).
- • Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1.
- • Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for SCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
- • Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Salamanca, , Spain
Lille, , France
Napoli, , Italy
Madrid, , Spain
Nyiregyhaza, , Hungary
Poitiers, , France
Barcelona, , Spain
Columbia, Missouri, United States
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Düsseldorf, , Germany
Marburg, , Germany
Roma, , Italy
Rozzano, , Italy
Firenze, , Italy
Pisa, , Italy
Nantes Cedex 1, , France
Pierre Benite, , France
Newport Beach, California, United States
Budapest, , Hungary
Marseille, , France
Bialystok, , Poland
Chestnut Hill, Massachusetts, United States
Santiago De Compostela, , Spain
Quebec, , Canada
Bydgoszcz, , Poland
Villingen Schwenningen, , Germany
Tubingen, , Germany
Catania, , Italy
Bologna, , Italy
łódź, , Poland
Hamilton, Ontario, Canada
Wiesbaden, , Germany
Pécs, , Hungary
Toulouse Cedex 9, , France
Zawadzkie, , Poland
Ste Foy, Quebec, Canada
Le Kremlin Bicêtre, , France
Padua, , Italy
Poitiers, , Canada
Cadiz, , Spain
Patients applied
Trial Officials
Tanya M Laidlaw, MD
Principal Investigator
Director of Translational Research in Allergy and Director of the Aspirin-Exacerbated Respiratory Disease (AERD) Centre at the Brigham and Women's Hospital.
Enrico Heffler, MD, PhD
Principal Investigator
Associate Professor of Internal Medicine and Consultant at the Personalized Medicine, Asthma and Allergy Unit at IRCCS Humanitas Research Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported