Nasal PolypsPhase 4NCT06750471
Dupixent Study for Alternate Administration
A Phase 4 study testing Dupilumab in people with Nasal Polyps and Sinusitis, run by Madigan Army Medical Center at 1 site in United States.
Trial summary
Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Polyps, Sinusitis, Chronic Disease
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2021to Dec 2025
- Phase
- Phase 4
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age=>18 y/o with recurrent CRSwNP based on reported symptoms and endoscopic assessment
- history of atleast 1 endoscopic sinus surgery
- Current use of intranasal corticosteroid spray or irrigation
- Active duty servicemembers must be in the area for at least 7 months after starting the medication to complete the necessary follow ups
Who cannot join
- Previous use of other biologic therapy in last 6 months
- if history of asthma, FEV1< 50%
- history of cystic fibrosis, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, kartagener syndrome, primary ciliary dyskinesia
- Patient is a pregnant woman, may become pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Efficacy of Alternate Dupilumab Schedule in Recurrent Chronic Rhinosinusitis With Nasal Polyposis Patients
Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.
Read the detailed description
Dupixent was recently approved by the FDA for chronic rhinosinusitis patients with nasal polyposis in April 2019. Literature support for this approval comes from results obtained from a landmark Phase III trial (LIBERTY SINUS-24 and SINUS-52) that were published in November 2019. The data suggests that Dupilumab improves subjective quality of life significantly in patients with chronic sinusitis with nasal polyposis and there is objective evidence of decreased disease burden and severity of other comorbidities (asthma, aspirin exacerbated respiratory disease). Therefore, there is robust scientific evidence supporting the use of this medication in chronic rhinosinusitis with nasal polyposis patients along with the FDA indication for usage of this medication in this subset of patients.
Otolaryngologists see and manage most (if not all) of chronic sinusitis patients with persistent symptoms and give recommendations for surgical and medical therapies. Given our unique ability to perform a detailed examination and provide medical and surgical care, investigators believe that this patient population will be best served with us making the determination of when to initiate the treatment if other treatment strategies fail. Given the cost associated with this medication (~ $45,630/patient/year based on price of $1,755/injection), investigators can make the judicious determination for when to prescribe this medication based on published evidence and guidelines in literature.
After careful assessment of LIBERTY study, most subjective and objective outcomes appear to show statistically and clinically significant benefit after 8 weeks of therapy. Moreover, one of the study arms had patients on this medication every 2 weeks until 26 weeks and then switched to every 4 weeks for the rest of the year. Given the apparent benefit of medication compared to placebo at 8 weeks, investigators propose that an alternate medication schedule with less frequent dosing after 8 weeks will be just as effective in improving subjective and objective outcomes in this patient population. If a non-inferior improvement is noted in the alternate medication schedule, then this will translate into significant cost saving to DoD and DHA (~$21,000/patient/year) when patients are placed on this medication due to the refractory nature of their disease.
Moreover, if the alternate schedule is just as effective, then this will validate use of this schedule in active duty service members (ADSM) during temporary duty or deployments to keep them medically fit and ready. Although topical steroid rinses are beneficial after surgery, the lack of distilled water in some austere environments prohibit usage and some patients have disease recurrence despite steroids and therefore require alternate medications or additional surgery. If the alternate regimen is proven to be non-inferior, then ADSMs or their medical team can carry the pre-made medication with them while following appropriate storage instructions according to drug information. Based on the FDA information website, Dupilumab can be stored below the room temperature (<77F or <25C) in pre-filled syringes up to 14 days or within refrigerator (between 2-8 C) until expiration. As long as these storage conditions can be met, ADSMs can continue this regimen while they are away. Additionally, if they are stable on long term Dupilumab therapy, there is potential for even longer time intervals between injections to help manage their chronic disease process.
- Conditions
- Nasal Polyps, Sinusitis, Chronic Disease
- Being tested
- Dupilumab
- Keywords
- Chronic rhinosinusitis, Dupilumab, Biologic Therapy
- Medical subject headings
- Nasal Polyps, Sinusitis, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabBiological
Also called Dupixent
Dupilumab is an anti-IL 4-13 biologic therapy that has been recently approved for use in recurrent chronic rhinosinusitis with nasal polyposis.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Regular Adminstration | Active comparator | Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 28 weeks Receives: Biological: Dupilumab |
| Arm B - Alternate Administration | Experimental | Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 8 weeks and then every 4 weeks up until 28 weeks Receives: Biological: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sinonasal outcome test - 22 over different time intervals
22 item questionnaire of impact of chronic rhinosinusitis on quality of life. Scored from 0-120: higher number = worse symptoms
Measured: Baseline, week 4, week 8, week 16 and week 28
Change in Lund Kennedy Score over different time intervals
Sinus endoscopy to objectively score the impact of drug on patient's disease process. Total points = 20 (10 on each side), higher score = worse objective data
Measured: Baseline, week 4, week 8, week 16 and week 28
Change in Total polyp score over different time intervals
Sinus endoscopy to objectively score the impact of drug on patient's disease process. Scored from 0-8, 4 on each side. Higher scores = worse polyp scores
Measured: Baseline, week 4, week 8, week 16 and week 28
Change in Rhinosinusitis Disability Index Score (RSDI) over different time intervals
Disability associated with chronic rhinosinusitis, Scored from 0-120: higher number = worse quality of life.
Measured: Baseline, week 4, week 8, week 16 and week 28
Secondary outcomes (4)
Change in IgE levels over different time intervals
Labs to evaluate the impact of Dupilimab administration in patients
Measured: Baseline, week 4, week 8, week 16 and week 28
Change in Eosinophil levels over different time intervals
Labs to evaluate the impact of Dupilimab administration in patients
Measured: Baseline, week 4, week 8, week 16 and week 28
Cost Savings between 2 treatment arms
Cost savings between the two treatment arms will be compared to see how cost to healthcare was saved with alternate therapy.
Measured: Ove the course of the study timeline - 28 weeks
Need for additional interventions or surgeries in each arm
We will assess if participants needed oral steroids or surgeries while being on dupixent therapy over the course of study to help manage their symptoms.
Measured: Over the course of the study timeline - 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start14 Oct 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Tripler Army Medical Center, Fort Belvoir Community Hospital, William Beaumont Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Renee M Serra, MD, Principal investigator, ENT/Audiology Department ChairRoy F Thomas, MD, Principal investigator, Rhinologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750471
- Sponsor's protocol ID
- 222008
- Status last verified
- Jan 2025
- First submitted
- 30 Aug 2021
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD information will only be available to the researchers participating in this multi-site trial. No outside researcher will be able to view this data or information.
Publications
Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19.
PubMed 31543428Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
PubMed 32077450Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J, Canonica GW, Deneyer L, Desrosiers M, Diamant Z, Han J, Heffler E, Hopkins C, Jankowski R, Joos G, Knill A, Lee J, Lee SE, Marien G, Pugin B, Senior B, Seys SF, Hellings PW. EUFOREA consensus on biologics for CRSwNP with or without asthma. Allergy. 2019 Dec;74(12):2312-2319. doi: 10.1111/all.13875. Epub 2019 Jul 15.
PubMed 31090937Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, Hellings P, Jiao L, Wang L, Evans RR, Pirozzi G, Graham NM, Swanson B, Hamilton JD, Radin A, Gandhi NA, Stahl N, Yancopoulos GD, Sutherland ER. Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):469-79. doi: 10.1001/jama.2015.19330.
PubMed 26836729Van Crombruggen K, Zhang N, Gevaert P, Tomassen P, Bachert C. Pathogenesis of chronic rhinosinusitis: inflammation. J Allergy Clin Immunol. 2011 Oct;128(4):728-32. doi: 10.1016/j.jaci.2011.07.049. Epub 2011 Aug 24.
PubMed 21868076Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
PubMed 19793277Senior BA, Glaze C, Benninger MS. Use of the Rhinosinusitis Disability Index (RSDI) in rhinologic disease. Am J Rhinol. 2001 Jan-Feb;15(1):15-20. doi: 10.2500/105065801781329428.
PubMed 11258649
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Alternate Dupilumab Schedule in Recurrent Chronic Rhinosinusitis With Nasal Polyposis Patients
- ClinicalTrials.gov ID
- NCT06750471
- Acronym / sponsor ID
- 222008
- Conditions
- Nasal Polyps, Sinusitis, Chronic Disease
- Keywords
- Chronic rhinosinusitis, Dupilumab, Biologic Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Collaborators
- Tripler Army Medical Center, Fort Belvoir Community Hospital, William Beaumont Army Medical Center
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.
Detailed description
Dupixent was recently approved by the FDA for chronic rhinosinusitis patients with nasal polyposis in April 2019. Literature support for this approval comes from results obtained from a landmark Phase III trial (LIBERTY SINUS-24 and SINUS-52) that were published in November 2019. The data suggests that Dupilumab improves subjective quality of life significantly in patients with chronic sinusitis with nasal polyposis and there is objective evidence of decreased disease burden and severity of other comorbidities (asthma, aspirin exacerbated respiratory disease). Therefore, there is robust scientific evidence supporting the use of this medication in chronic rhinosinusitis with nasal polyposis patients along with the FDA indication for usage of this medication in this subset of patients.
Otolaryngologists see and manage most (if not all) of chronic sinusitis patients with persistent symptoms and give recommendations for surgical and medical therapies. Given our unique ability to perform a detailed examination and provide medical and surgical care, investigators believe that this patient population will be best served with us making the determination of when to initiate the treatment if other treatment strategies fail. Given the cost associated with this medication (~ $45,630/patient/year based on price of $1,755/injection), investigators can make the judicious determination for when to prescribe this medication based on published evidence and guidelines in literature.
After careful assessment of LIBERTY study, most subjective and objective outcomes appear to show statistically and clinically significant benefit after 8 weeks of therapy. Moreover, one of the study arms had patients on this medication every 2 weeks until 26 weeks and then switched to every 4 weeks for the rest of the year. Given the apparent benefit of medication compared to placebo at 8 weeks, investigators propose that an alternate medication schedule with less frequent dosing after 8 weeks will be just as effective in improving subjective and objective outcomes in this patient population. If a non-inferior improvement is noted in the alternate medication schedule, then this will translate into significant cost saving to DoD and DHA (~$21,000/patient/year) when patients are placed on this medication due to the refractory nature of their disease.
Moreover, if the alternate schedule is just as effective, then this will validate use of this schedule in active duty service members (ADSM) during temporary duty or deployments to keep them medically fit and ready. Although topical steroid rinses are beneficial after surgery, the lack of distilled water in some austere environments prohibit usage and some patients have disease recurrence despite steroids and therefore require alternate medications or additional surgery. If the alternate regimen is proven to be non-inferior, then ADSMs or their medical team can carry the pre-made medication with them while following appropriate storage instructions according to drug information. Based on the FDA information website, Dupilumab can be stored below the room temperature (<77F or <25C) in pre-filled syringes up to 14 days or within refrigerator (between 2-8 C) until expiration. As long as these storage conditions can be met, ADSMs can continue this regimen while they are away. Additionally, if they are stable on long term Dupilumab therapy, there is potential for even longer time intervals between injections to help manage their chronic disease process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Regular Adminstration | Active comparator | Biological: DupilumabEligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 28 weeks |
| Arm B - Alternate Administration | Experimental | Biological: DupilumabEligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 8 weeks and then every 4 weeks up until 28 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age=>18 y/o with recurrent CRSwNP based on reported symptoms and endoscopic assessment
- history of atleast 1 endoscopic sinus surgery
- Current use of intranasal corticosteroid spray or irrigation
- Active duty servicemembers must be in the area for at least 7 months after starting the medication to complete the necessary follow ups
Key exclusion criteria (4 listed)
- Previous use of other biologic therapy in last 6 months
- if history of asthma, FEV1< 50%
- history of cystic fibrosis, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, kartagener syndrome, primary ciliary dyskinesia
- Patient is a pregnant woman, may become pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentDupilumab is an anti-IL 4-13 biologic therapy that has been recently approved for use in recurrent chronic rhinosinusitis with nasal polyposis. | Biological | Arm A - Regular Adminstration, Arm B - Alternate Administration |
Primary outcome
Change in Sinonasal outcome test - 22 over different time intervals
Time frame: Baseline, week 4, week 8, week 16 and week 28
22 item questionnaire of impact of chronic rhinosinusitis on quality of life. Scored from 0-120: higher number = worse symptoms
Change in Lund Kennedy Score over different time intervals
Time frame: Baseline, week 4, week 8, week 16 and week 28
Sinus endoscopy to objectively score the impact of drug on patient's disease process. Total points = 20 (10 on each side), higher score = worse objective data
Change in Total polyp score over different time intervals
Time frame: Baseline, week 4, week 8, week 16 and week 28
Sinus endoscopy to objectively score the impact of drug on patient's disease process. Scored from 0-8, 4 on each side. Higher scores = worse polyp scores
Change in Rhinosinusitis Disability Index Score (RSDI) over different time intervals
Time frame: Baseline, week 4, week 8, week 16 and week 28
Disability associated with chronic rhinosinusitis, Scored from 0-120: higher number = worse quality of life.
4 secondary outcomes
Change in IgE levels over different time intervals
Time frame: Baseline, week 4, week 8, week 16 and week 28
Change in Eosinophil levels over different time intervals
Time frame: Baseline, week 4, week 8, week 16 and week 28
Cost Savings between 2 treatment arms
Time frame: Ove the course of the study timeline - 28 weeks
Need for additional interventions or surgeries in each arm
Time frame: Over the course of the study timeline - 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Background: PubMed 31543428Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19.
- Background: PubMed 32077450Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
- Background: PubMed 31090937Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J, Canonica GW, Deneyer L, Desrosiers M, Diamant Z, Han J, Heffler E, Hopkins C, Jankowski R, Joos G, Knill A, Lee J, Lee SE, Marien G, Pugin B, Senior B, Seys SF, Hellings PW. EUFOREA consensus on biologics for CRSwNP with or without asthma. Allergy. 2019 Dec;74(12):2312-2319. doi: 10.1111/all.13875. Epub 2019 Jul 15.
- Background: PubMed 26836729Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, Hellings P, Jiao L, Wang L, Evans RR, Pirozzi G, Graham NM, Swanson B, Hamilton JD, Radin A, Gandhi NA, Stahl N, Yancopoulos GD, Sutherland ER. Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):469-79. doi: 10.1001/jama.2015.19330.
- Background: PubMed 21868076Van Crombruggen K, Zhang N, Gevaert P, Tomassen P, Bachert C. Pathogenesis of chronic rhinosinusitis: inflammation. J Allergy Clin Immunol. 2011 Oct;128(4):728-32. doi: 10.1016/j.jaci.2011.07.049. Epub 2011 Aug 24.
- Background: PubMed 19793277Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
- Background: PubMed 11258649Senior BA, Glaze C, Benninger MS. Use of the Rhinosinusitis Disability Index (RSDI) in rhinologic disease. Am J Rhinol. 2001 Jan-Feb;15(1):15-20. doi: 10.2500/105065801781329428.
- Individual participant dataSharing planned: No. The IPD information will only be available to the researchers participating in this multi-site trial. No outside researcher will be able to view this data or information.
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Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
RecruitingObservational study
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee M Serra, MD principal investigator
ENT/Audiology Department Chair
Roy F Thomas, MD principal investigator
Rhinologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab in people with Nasal Polyps and Sinusitis, run by Madigan Army Medical Center at 1 site in United States.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sinonasal outcome test - 22 over different time intervals (time frame: Baseline, week 4, week 8, week 16 and week 28). The study lists 4 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 NCT06750471, which also lists 7 linked publications.
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 17 Jan 2025.