Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461949
Status:
WITHDRAWN
Last Update Posted:
2024-07-15
First Post:
2024-06-08
Brief Title:
Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis AFRS on a Background Therapy With Intranasal Corticosteroid Spray
Sponsor:
National Institute on Deafness and Other Communication Disorders NIDCD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized 52-Week Treatment Double-Blind Placebo-Controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis AFRS on a Background Therapy With Intranasal Corticosteroid Spray
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed by sponsor lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Allergic fungal rhinosinusitis AFRS is a severe type of sinus infection People with AFRS develop heavy mucus and growths called polyps that apply pressure to the sinuses and block their breathing Surgery can remove the polyps but they often grow back Researchers want to test an approved drug they believe may help people with AFRS
Objective
To test a drug Dupilumab in people with AFRS
Eligibility
People aged 18 years or older with suspected AFRS who are scheduled to undergo surgery for nasal polyps
Design
Participants will have several tests before their surgery They will have imaging scans of their sinuses They will have an endoscopic exam A tube with a camera and a light will be inserted into their sinuses They may give blood and mucus samples They will have standard treatment with nasal sprays for 2 to 6 weeks before their surgery
Excess nasal tissue removed during the surgery will be collected for research Then they will begin treatment with the study drug
Dupilumab is injected under the skin Some participants will receive the study drug Some will receive a placebo injections The placebo injections are just like the study drug but contain no medicine Participants will not know which injections they are getting
All participants will administer the injections to themselves at home They will do this every 2 weeks for 1 year after the surgery They will have a clinic visit 16 weeks after surgery
Participants will have follow-up for 12 weeks after treatment ends
Allergic fungal rhinosinusitis AFRS is a severe type of sinus infection People with AFRS develop heavy mucus and growths called polyps that apply pressure to the sinuses and block their breathing Surgery can remove the polyps but they often grow back Researchers want to test an approved drug they believe may help people with AFRS
Objective
To test a drug Dupilumab in people with AFRS
Eligibility
People aged 18 years or older with suspected AFRS who are scheduled to undergo surgery for nasal polyps
Design
Participants will have several tests before their surgery They will have imaging scans of their sinuses They will have an endoscopic exam A tube with a camera and a light will be inserted into their sinuses They may give blood and mucus samples They will have standard treatment with nasal sprays for 2 to 6 weeks before their surgery
Excess nasal tissue removed during the surgery will be collected for research Then they will begin treatment with the study drug
Dupilumab is injected under the skin Some participants will receive the study drug Some will receive a placebo injections The placebo injections are just like the study drug but contain no medicine Participants will not know which injections they are getting
All participants will administer the injections to themselves at home They will do this every 2 weeks for 1 year after the surgery They will have a clinic visit 16 weeks after surgery
Participants will have follow-up for 12 weeks after treatment ends
Detailed Description:
Study Description
Multicenter randomized double-blind placebo-controlled study comparing the efficacy of dupilumab to placebo in allergic fungal rhinosinusitis AFRS subjects after sinus surgery on a background treatment with intranasal corticosteroid spray
Study periods
The clinical trial consists of 4 periods
-Run-in period 2 weeks 4 weeks
All participants will enter a run-in period of 2-6 weeks receiving saline irrigations and Intranasal Corticosteroids per the treating physician All oral steroids and antibiotics will be stopped
-Ethmoid Tissue Collection period 7 days 4 weeks
Participants will undergo surgery as scheduled per standard of care Ethmoid tissue will be collected from all subjects at the time of surgery
-Randomized treatment 52 weeks - 7 days
Participants will be randomized to one of the following treatments
Arm A dupilumab 300 mg subcutaneous SC every two weeks for 52 weeks
Arm B placebo given SC every two weeks for 52 weeks
Posttreatment period 12 weeks - 7 days
After completing 52 weeks of treatment with IMP or following early discontinuation of IMP subjects will be instructed to
Return to the study site for the last scheduled visits for physical examination nasal endoscopy Nasal Polyps Score NPS Patient-Reported Outcomes PROsSinonasal Outcomes Test-SNOT-22- and Asthma Control Questionnaire -ACQ- FEV1 measurement in those with asthma and safety
Continue on stable dose of INCS spray during the posttreatment period
Report any adverse event AE
Co-Primary Objectives
Determine the efficacy of dupilumab in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for AFRS as measured by change in the mLK score
Evaluate the effect of dupilumab on oral corticosteroid utilization following complete sinus surgery for AFRS
Secondary Objectives
To evaluate the effect of dupilumab on
Prevention of revision surgery for AFRS
Secondary objective measures of sinonasal inflammation following sinus surgery using NPS and LMS
Lower airway dysfunction following sinus surgery in the subgroup of participants with asthma approximately 25
Upper and lower airway disease-specific health-related quality of life as measured by ACQ and SNOT-22
Reducing utilization of rescue medications for acute exacerbations of CRS following sinus surgery
Primary Endpoints
Change from baseline at 52 weeks both within and between treatment and placebo arms
Endoscopic modified Lund-Kennedy mLK score
Incidence of oral corticosteroid utilization per participant
Secondary Endpoints
Change from baseline at 52 weeks both within and between treatment and placebo arms
Prevalence of revision sinus surgery for recurrent nasal polyps and comparison of survival curves
Endoscopic nasal polyp score NPS
CT generated Lund-McKay score
Spirometry for participants with comorbid asthma
22-item sinonasal outcomes test SNOT-22
Asthma Control Questionnaire ACQ
Prevalence of oral topical corticosteroid utilization per treatment cohort
Incidence of oral topical antibiotic utilization per subject
Prevalence of oral topical antibiotic utilization per treatment cohort
Multicenter randomized double-blind placebo-controlled study comparing the efficacy of dupilumab to placebo in allergic fungal rhinosinusitis AFRS subjects after sinus surgery on a background treatment with intranasal corticosteroid spray
Study periods
The clinical trial consists of 4 periods
-Run-in period 2 weeks 4 weeks
All participants will enter a run-in period of 2-6 weeks receiving saline irrigations and Intranasal Corticosteroids per the treating physician All oral steroids and antibiotics will be stopped
-Ethmoid Tissue Collection period 7 days 4 weeks
Participants will undergo surgery as scheduled per standard of care Ethmoid tissue will be collected from all subjects at the time of surgery
-Randomized treatment 52 weeks - 7 days
Participants will be randomized to one of the following treatments
Arm A dupilumab 300 mg subcutaneous SC every two weeks for 52 weeks
Arm B placebo given SC every two weeks for 52 weeks
Posttreatment period 12 weeks - 7 days
After completing 52 weeks of treatment with IMP or following early discontinuation of IMP subjects will be instructed to
Return to the study site for the last scheduled visits for physical examination nasal endoscopy Nasal Polyps Score NPS Patient-Reported Outcomes PROsSinonasal Outcomes Test-SNOT-22- and Asthma Control Questionnaire -ACQ- FEV1 measurement in those with asthma and safety
Continue on stable dose of INCS spray during the posttreatment period
Report any adverse event AE
Co-Primary Objectives
Determine the efficacy of dupilumab in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for AFRS as measured by change in the mLK score
Evaluate the effect of dupilumab on oral corticosteroid utilization following complete sinus surgery for AFRS
Secondary Objectives
To evaluate the effect of dupilumab on
Prevention of revision surgery for AFRS
Secondary objective measures of sinonasal inflammation following sinus surgery using NPS and LMS
Lower airway dysfunction following sinus surgery in the subgroup of participants with asthma approximately 25
Upper and lower airway disease-specific health-related quality of life as measured by ACQ and SNOT-22
Reducing utilization of rescue medications for acute exacerbations of CRS following sinus surgery
Primary Endpoints
Change from baseline at 52 weeks both within and between treatment and placebo arms
Endoscopic modified Lund-Kennedy mLK score
Incidence of oral corticosteroid utilization per participant
Secondary Endpoints
Change from baseline at 52 weeks both within and between treatment and placebo arms
Prevalence of revision sinus surgery for recurrent nasal polyps and comparison of survival curves
Endoscopic nasal polyp score NPS
CT generated Lund-McKay score
Spirometry for participants with comorbid asthma
22-item sinonasal outcomes test SNOT-22
Asthma Control Questionnaire ACQ
Prevalence of oral topical corticosteroid utilization per treatment cohort
Incidence of oral topical antibiotic utilization per subject
Prevalence of oral topical antibiotic utilization per treatment cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001856-DC | None | None | None |