Dupixent Study for Alternate Administration

NCT06750471 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 222008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.

Conditions

Nasal Polyps; Sinusitis; Chronic Disease

Keywords

Chronic rhinosinusitis; Dupilumab; Biologic Therapy

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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.

  Baseline, week 4, week 8, week 16 and week 28

Secondary Outcomes (4)

• Change in IgE levels over different time intervals

  Baseline, week 4, week 8, week 16 and week 28

• Change in Eosinophil levels over different time intervals

  Baseline, week 4, week 8, week 16 and week 28

• Cost Savings between 2 treatment arms

  Ove the course of the study timeline - 28 weeks

• Need for additional interventions or surgeries in each arm

  Over the course of the study timeline - 28 weeks

Study Arms (2)

Arm A - Regular Adminstration

ACTIVE COMPARATOR

Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 28 weeks

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

Biological: Dupilumab

Interventions

Dupilumab BIOLOGICAL

Dupilumab is an anti-IL 4-13 biologic therapy that has been recently approved for use in recurrent chronic rhinosinusitis with nasal polyposis.

Also known as: Dupixent

Arm A - Regular Adminstration; Arm B - Alternate Administration

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• Tripler Army Medical Center: collaborator
• Fort Belvoir Community Hospital: collaborator
• William Beaumont Army Medical Center: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (7)

• 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.

  PMID: 31543428 BACKGROUND

• Fokkens 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.

  PMID: 32077450 BACKGROUND

• Fokkens 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.

  PMID: 31090937 BACKGROUND

• Bachert 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.

  PMID: 26836729 BACKGROUND

• Van 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.

  PMID: 21868076 BACKGROUND

• Hopkins 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.

  PMID: 19793277 BACKGROUND

• Senior 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.

  PMID: 11258649 BACKGROUND

MeSH Terms

Conditions

Nasal Polyps; Sinusitis; Chronic Disease

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Renee M Serra, MD

  ENT/Audiology Department Chair

  PRINCIPAL INVESTIGATOR

• Roy F Thomas, MD

  Rhinologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: December 27, 2024
• Study Start: October 14, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)