Dupilumab in CRSsNP

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis, Sinus Disorder, Respiratory Disorder

In brief

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo * To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo * To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo * Assessment of immunogenicity to dupilumab over time compared to placebo

Key facts

Study ID

NCT04678856

Run by

Sanofi

People needed

71

Starts

2020-12-02

Expected to finish

2024-01-29

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be at least 18 years of age at the time of signing the informed consent form (ICF).
• Participants must have bilateral inflammation of paranasal sinuses in CT scan with LMK ≥8 and bilateral ethmoid opacification before randomization.
• Participants must have ongoing symptoms of loss of smell and rhinorrhea (anterior/posterior) of any severity, with or without facial pain/pressure for at least 12 consecutive weeks by Visit 1.
• Participants must have ongoing symptoms of nasal congestion (NC)/obstruction at least 12 consecutive weeks before Visit 1 and a NC score of ≥ 2 at Visit 1 (day score) and Visit 2 (weekly average score).
• Participants must have sTSS (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score).
• Participants must have one of the 2 following features:
• Prior sinonasal surgery (see note at end of section 5.2 for definitions of sinonasal surgery) for CRS,
• Treatment with systemic corticosteroids (SCS) therapy for CRS as defined by any dose and duration within the prior 2 years before screening (Visit 1) or intolerance/contraindication to SCS.

You may not qualify if…

• Participants with nasal conditions/concomitant nasal diseases such as nasal polyposis in endoscopy at Visit 1 or with history of nasal polyposis etc., making them non-evaluable at Visit 1 or for the primary efficacy
• Nasal cavity malignant tumor and benign tumors.
• Forced expiratory volume (FEV1) ≤50% of predicted normal at Visit 1.
• Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis.
• Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect participation in the study
• Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
• Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
• Known or suspected immunodeficiency
• History of malignancy within 5 years before Visit 1, except completely treated in situ carcinoma of the cervix, and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the Screening Visit 1 or during the screening period.
• History of systemic hypersensitivity or anaphylaxis to dupilumab or any of its excipients.
• Participants in prior dupilumab clinical trial or have been treated with commercially available dupilumab within 12 months or who discontinued dupilumab use due to adverse event.
• Participants who are treated with intranasal corticosteroid drops; intranasal steroid emitting devices/stents; nasal spray using exhalation delivery system, such as Xhance™, during screening period.
• Participants on unstable dose of intranasal corticosteroids (INCS) spray 4 weeks prior to Screening Visit (Visit1) and during screening period.
• Participants who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1.
• Participants who have taken:
• Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 5 half-lives prior to Visit 1
• Any investigational mAb within 5 half-lives prior to Visit 1
• Anti-IgE therapy (omalizumab) within 4 months prior to Visit 1.
• Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1
• Leukotriene antagonists/modifiers unless participant is on a continuous treatment for at least 30 days prior to Visit 1.
• Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy or change its dose during the screening or treatment period.
• Participants received SCS during screening period (between Visit 1 and Visit 2).
• Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to Screening Visit (Visit 1).
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Bensch Clinical Research LLC Site Number : 8400015 — Stockton, California, United States
• Colorado Allergy and Asthma Centers, PC Site Number : 8400003 — Denver, Colorado, United States
• University of Missouri Health System Site Number : 8400016 — Columbia, Missouri, United States
• Nebraska Medical Research Institute Site Number : 8400007 — Papillion, Nebraska, United States
• Optimed Research, LTD Site Number : 8400017 — Columbus, Ohio, United States
• Vital Prospects Clinical Research Institute, P.C. Site Number : 8400004 — Tulsa, Oklahoma, United States
• Essential Medical Research, LLC Site Number : 8400014 — Tulsa, Oklahoma, United States
• Pharmaceutical Research & Consulting, Inc. Site Number : 8400006 — Dallas, Texas, United States
• Alamo ENT Associates Site Number : 8400021 — San Antonio, Texas, United States
• Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400009 — Norfolk, Virginia, United States
• Investigational Site Number : 0320002 — Buenos Aires, Argentina
• Investigational Site Number : 0320003 — Ciudad Autonoma Buenos Aires, Argentina
• Investigational Site Number : 0320001 — Ciudad Autonoma Buenos Aires, Argentina
• Investigational Site Number : 0560002 — Ghent, Belgium
• Investigational Site Number : 0560001 — Leuven, Belgium
• Investigational Site Number : 1240013 — Vancouver, British Columbia, Canada
• Investigational Site Number : 1240010 — Hamilton, Ontario, Canada
• Investigational Site Number : 1240007 — Kingston, Ontario, Canada
• Investigational Site Number : 1240016 — London, Ontario, Canada
• Investigational Site Number : 1240001 — Montreal, Quebec, Canada
• Investigational Site Number : 1240012 — Montreal, Quebec, Canada
• Investigational Site Number : 1240002 — Trois-Rivières, Quebec, Canada
• Investigational Site Number : 1240005 — Québec, Canada
• Investigational Site Number : 1240003 — Québec, Canada
• Sacramento Ear, Nose & Throat Site Number : 8400010 — Roseville, California, United States

Full record on ClinicalTrials.gov

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