Trial Review

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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
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
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.