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AsthmaPhase 3NCT06740045

Opening the "Black Box" on Tezepelumab's Effect on Chronic Rhinosinusitis With Severe Asthma

A Phase 3 study testing Tezepelumab in people with Asthma and Chronic Rhinosinusitis With Nasal Polyps, run by Dr. Andrew Thamboo, MD.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study explores how chronic rhinosinusitis (CRS) and asthma share a common inflammatory process, particularly affecting patients with both conditions. Interaction between immune cells (Interleukins) and Th2 cytokines, such as TSLP, exacerbates asthma control in CRS patients, especially those with nasal polyps… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Tezepelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jan 2025to Jun 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be ≥19 of age at the time of signing the informed consent form
  • Capable of giving signed informed consent.
  • Having CRSwNP based on clinical symptoms and/or radiographic or endoscopic evidence of inflammation in their upper airways (Diagnosis consistent with EPOS 2020)(2)and severe asthma:
  • SA based on GINA criteria (37) and confirmed with spirometry and assessmenton the previous history of asthma (a pre-post bronchodilator spirometry ormethacholine challenge to document the positive or negative history of asthmawill be performed if there is no clinical record).
  • Nasal polyp score (NPS) of at least 2 on each side
  • Females of childbearing potential must commit using an acceptable method of birthcontrol for the duration of the study and they must have a negative urine pregnancy test ateach study visit
  • Not expecting to have surgery within the next 7 months

Who cannot join

  • Have previously undergone sinus surgery or nasal polypectomy
  • A history of organ transplantation such as lung transplantation
  • Previously or currently using immunomodulator medications or antihistamines
  • A history of auto-immune diseases
  • Current or past sinonasal or bronchial tumors
  • Currently using systemic or oral corticosteroids
Show all 27Show fewer
  • Women who are pregnant, plan to become pregnant, or breastfeed during the trial
  • Current participation in any other interventional treatment trials
  • Compliance: is unlikely to comply with study visits based on investigator judgment:
  • Diagnosed or suspected malignant or premalignant nasal disease (e.g. SchniderianPapilloma, unilateral nasal polyposis)
  • Fungal rhinosinusitis (CT/Histology), positive Aspergillus skin prick testing and/orpositive Aspergillus IgE RAST (Radioallergosorbent) testing
  • Malignant neoplasm within 5 years (from screening) excluding basal cell or squamouscell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterinecervix treated locally and without metastatic disease for 3 years.
  • Active bleeding disorders, and/or inability to support interruption to anticoagulant or anti-platelet therapies for nasal biopsy.
  • Severe nasal deformity precluding endoscopic assessment/biopsy of postnasal space
  • Have an acute or chronic infection (excluding that related to CRS) requiring managementas follows:
  • Currently on any treatment for a chronic infection such as pneumocystis,cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria
  • Hospitalisation solely for the treatment of proven infection requiring parenteral (IV orIM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60days of Day 1
  • Proven severe infection requiring outpatient treatment with parenteral (IV or IM)antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 daysof Day 1. Prophylactic anti-infective treatment is allowed.
  • Known positive human immunodeficiency virus (HIV) status
  • Known positive Hepatitis B (HB) or Hepatitis C status
  • Have clinical evidence of significant unstable or uncontrolled acute or chronic diseaseswhich, in the opinion of the principal investigator, could confound the results of the study orput the participant at undue risk
  • Have a planned surgical procedure, laboratory abnormality, or condition that, in theopinion of the principal investigator, makes the participant unsuitable for the study.
  • Have received any investigational agent (that is not approved for sale in Canada) within60 days of Day 1
  • Smoking history; current or former smokers with a smoke history of packs year >15
  • Subjects with parasitic (helminthic) infection
  • Subjects with hypersensitivity; with allergy/intolerance to a monoclonal antibody or biologics
  • Subjects allergic to Aspirin (ASA) and non-steroidal anti-inflammatory drugs (NSAIDs)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Andrew Thamboo, MD contact

604-250-4174

andrew.thamboo@gmail.com

Leonora Beltran contact

604-250-4174

lbeltranjimenez@providencehealth.bc.ca

About this study

The study explores how chronic rhinosinusitis (CRS) and asthma share a common inflammatory process, particularly affecting patients with both conditions. Interaction between immune cells (Interleukins) and Th2 cytokines, such as TSLP, exacerbates asthma control in CRS patients, especially those with nasal polyps (CRSwNP). TSLP plays a pivotal role in initiating and maintaining airway inflammation in both diseases. Tezepelumab, a biologic therapy targeting TSLP, shows promise in reducing inflammation markers in severe asthma but its impact on CRSwNP and quality of life remains unclear. The study proposes investigating Tezepelumab's efficacy in treating CRSwNP and severe asthma to inform future biologic therapies.

Read the detailed description

The investigators hypothesize that TSLP blockade with Tezepelumab will a) reduce upper airway inflammation based on histological, inflammatory, and remodeling biomarkers, that are evident in the airway remodeling process and b) correlate to a positive clinical response. Thus, nasal samples from chronic rhinosinusitis with nasal polyps (CRSwNP) patients with Severe Asthma (SA) pre- and post-treatment will exhibit inflammatory biomarkers and histopathological evidence that could prove responsive to the Tezepelumab.

The overall research objectives are to evaluate the effect of study intervention (Tezepelumab) on CRSwNP-SA outcomes through a) evaluating the sinonasal inflammatory profile, histopathological features, and remodeling biomarkers and b) investigating the impact of Tezepelumab on the CRSwNP-related clinical outcomes in the treated study subjects.

Being tested
Tezepelumab
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TezepelumabBiological

    Also called Teszpire

    10 patients will receive teszpire

Study groups in NCT06740045
Study groupRoleWhat they receive
TezepelumabExperimentalTezepelumab 210 mg subcutaneous injection every 4 weeks to all 10 participants
Receives: Biological: Tezepelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eosinophil Count

    Measurement of eosinophil count in tissue samples. Cells per high power field (HPF) or cells per millimeter squared (cells/mm²).

    Measured: From baseline to 24 weeks

  2. Neutrophil count

    Measurement of neutrophil count in tissue samples. Cells per high power field (HPF) or cells per millimeter squared (cells/mm²).

    Measured: From baseline to 24 weeks.

  3. Basement Membrane Thickness

    Measurement of the thickness of the basement membrane in tissue samples. Micrometers (µm)

    Measured: From baseline to 24 weeks

  4. Fibrosis

    Assessment of the extent of fibrosis in tissue samples, which may involve scoring systems or quantitative measurements

    Measured: From baseline to 24 weeks

  5. Squamous Metaplasia

    Immunohistochemical staining will be used to identify the presence of squamous metaplasia, with scoring based on percentage of positive cells.

    Measured: From baseline to 24 weeks

  6. Lymphocytic Proliferation

    Lymphocytic proliferation will be assessed using immunohistochemistry (IHC) to measure the Ki-67 proliferation index in tissue samples, specifically identifying the percentage of Ki-67-positive lymphocytes

    Measured: From baseline to 24 weeks

Secondary outcomes (12)

  1. Immunoglobulin leves

    IgE, IgG, IgA,

    Measured: 24 weeks

  2. Th2 Cytokines

    Measurement of Th2 cytokines such as IL-4, IL-5, IL-13

    Measured: 24 weeks

  3. Th1/Th17 Cytokines

    Measurement of Th1/Th17 cytokines such as IFN-γ and IL-17.

    Measured: 24 weeks

  4. Myeloperoxidase (MPO)

    Measurement of MPO levels in sinonasal samples or serum.

    Measured: 24 weeks

  5. Interferon-γ (IFN-γ)

    Measurement of IFN-γ levels in sinonasal samples or serum.

    Measured: 24 weeks

  6. SNOT-22 (Sino-Nasal Outcome Test 22-item)

    Assessment of sinonasal symptoms and their impact on quality of life using a 22-item questionnaire.

    Measured: 24 weeks

  7. Health-Related Quality of Life

    Measurement of health-related quality of life using the EuroQualityOfLife 5-Dimension 5-Level (EQ-5D-5L) instrument.

    The EQ-5D-5L includes 5 dimensions of health (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression) with 5 levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems).

    For the overall EQ-5D-5L index score, it typically ranges from:

    Minimum Value: 0 (representing death) Maximum Value: 1 (representing perfect health) In some versions, a negative score can be obtained, which represents a state "worse than death."

    Measured: 24 weeks

  8. Asthma Control Questionnaire

    Asthma control will be assessed using the 5-question Asthma Control Questionnaire (ACQ-5), which includes the following domains: symptoms, reliever medication use, and limitations on daily activities. Each question is rated on a scale from 0 (no symptoms) to 6 (maximum symptoms). The total score is the sum of the individual responses, with possible scores ranging from 0 to 30

    Measured: 24 weeks

  9. Epithelial Changes

    Measurement of epithelial changes in sinonasal tissues, including alterations in epithelial thickness, cell type, and structural modifications.

    Measured: 24 weeks

  10. Modified Lund-Kennedy Endoscopy Score

    Evaluation of sinonasal pathology using the Modified Lund-Kennedy endoscopy scoring system, which assesses factors like nasal polyp size, discharge, and mucosal appearance. Typically ranges from 0 to 24, where higher scores indicate more severe disease.

    Measured: 24 weeks

  11. Lund-Mackay CT Scan Score

    Evaluation of sinus opacifications and other CT scan findings using the Lund-Mackay scoring system, which assesses the extent of sinus disease. Typically ranges from 0 to 24. 0 (no opacification) to 2 (complete opacification)

    Measured: 24 weeks

  12. Changes in smell

    Measurement of changes in olfactory function using the University of Pennsylvania Smell Identification Test (UPSIT)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionMar 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The proposed design is a 24-week pilot study to investigate the histo-inflammatory and remodeling profiles and clinical outcomes of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) patients with Severe Asthma (SA) treated with Tezepelumab. The investigators plan to recruit approximately 10 subjects with (CRSwNP) and severe asthma as a "proof of concept" study. Eligible subjects will be requested to participate in the study for a maximum of 24 weeks, during which subjects will remain on their existing standard of care therapy. At Visit 2 (week 0), subjects will receive either add-on Tezepelumab (210 mg) during the 24-week treatment period. Study medication will be administered subcutaneously (SC) every 4 weeks for a total of 6 doses.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06740045
Sponsor's protocol ID
H24-02151
Status last verified
Dec 2024
First submitted
13 Aug 2024
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tezepelumab in people with Asthma and Chronic Rhinosinusitis With Nasal Polyps, run by Dr. Andrew Thamboo, MD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew Thamboo, MD (604-250-4174, andrew.thamboo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eosinophil Count (time frame: From baseline to 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06740045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.

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