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Trial registered on ANZCTR


Registration number
ACTRN12624000716561
Ethics application status
Approved
Date submitted
21/05/2024
Date registered
11/06/2024
Date last updated
22/09/2024
Date data sharing statement initially provided
11/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of biologics on patients with nasal polyp eosinophilia.
Scientific title
Spatial mapping of Dupilumab-induced molecular changes in nasal polyp eosinophilia and type 2 inflammation: towards optimised treatment
Secondary ID [1] 311594 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasal polyps 332978 0
Eosinophilic chronic rhinosinusitis 333928 0
Type 2 Inflammation 333929 0
Condition category
Condition code
Inflammatory and Immune System 329692 329692 0 0
Other inflammatory or immune system disorders
Respiratory 330599 330599 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with Nasal Polyps (NP) treated with Dupilumab for a 26 week plus a post-treatment visit at three months.

The Dupilumab treatment will consist of the following:

Dupilumab
• Trade name: Dupixent
• Dosage regimen: for chronic rhinosinusitis 300mg subcutaneous injection once every 2 weeks for 24 weeks.
• Participants will also undergo a blood test, endoscopy and FENO (fractional exhaled nitric oxide) test at each second visit (once per month). Adverse and serious adverse event recording will occur at each visit.
Intervention code [1] 328048 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337477 0
Histopathological eosinophilic count
Timepoint [1] 337477 0
9 months post baseline visit
Secondary outcome [1] 435629 0
Airway inflammatory changes
Timepoint [1] 435629 0
Every 4 weeks for 6 months post baseline treatment.
Secondary outcome [2] 435630 0
Nasal polyp size
Timepoint [2] 435630 0
Every 4 weeks for 6 months post-baseline
Secondary outcome [3] 435959 0
Blood eosinophil count
Timepoint [3] 435959 0
Every 4 weeks for 6 months post-baseline.

Eligibility
Key inclusion criteria
• Adult patients with nasal polyp eosinophilia whose condition is not fully managed by current standard of care
• Not currently receiving Mepolizumab, Dupilumab or Benralizumab treatment
• Patients who do not meet the PBS criteria for severe lower airway disease
• Body weight: A minimum body weight >=40 kilograms (kg) at Visit 1
• Gender: Male or female.
• Informed consent: Capable of giving signed written informed consent and willingness to participate to and comply with the study
• Age over 18 Years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Subjects with known hypersensitivity to mepolizumab and/or dupilumab
• Subjects with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis.
• Subjects with known immunodeficiency
• Subjects with cystic fibrosis
• Pregnant subjects or subjects currently lactating as the effect on human pregnancy is unknown.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/06/2024
Actual
21/08/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
25
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26214 0
Sydney ENT Clinic - Darlinghurst
Recruitment postcode(s) [1] 42180 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 315901 0
Commercial sector/Industry
Name [1] 315901 0
Sanofi
Country [1] 315901 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 318048 0
None
Name [1] 318048 0
Address [1] 318048 0
Country [1] 318048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314748 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 314748 0
https://svhs.org.au/home/research-education/research-office
Ethics committee country [1] 314748 0
Australia
Date submitted for ethics approval [1] 314748 0
03/05/2024
Approval date [1] 314748 0
16/05/2024
Ethics approval number [1] 314748 0
2019/ETH03266

Summary
Brief summary
This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with NP treated with Dupilumab for a 26 week plus a post-treatment visit at three months. At baseline and every 2 weeks patients will have a clinical assessment and complete a series of questionnaires. A blood sample and a nasal mucosal biopsy will be collected every 4 weeks. Protein and RNA analysis will be performed using the GeoMx™ DSP /CosMx™ single cell SMI platforms on tissue samples at baseline, week 4, week 12 and week 26.

The objective of this study is to identify and assess the tissue histopathological changes in response to mepolizumab and/or dupilumab therapy in patients with nasal polyp eosinophilia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132598 0
A/Prof Nicholas West
Address 132598 0
Griffith University. Building G40_91.7 - Parklands Drive, Southport, QLD, 4215
Country 132598 0
Australia
Phone 132598 0
+617 56780899
Fax 132598 0
Email 132598 0
[email protected]
Contact person for public queries
Name 132599 0
Rebecca Morgan
Address 132599 0
Griffith University. Building G40_4.36 - 58 Parklands Drive, Southport, QLD,4215
Country 132599 0
Australia
Phone 132599 0
+617 56780358
Fax 132599 0
Email 132599 0
[email protected]
Contact person for scientific queries
Name 132600 0
Rebecca Morgan
Address 132600 0
Griffith University, Building G40_4.36 - 58 Parklands Drive, Southport, QLD,4215
Country 132600 0
Australia
Phone 132600 0
+617 56780358
Fax 132600 0
Email 132600 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data is only shared with the individual participants themselves.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.