Dupilumab in CRSsNP (Liberty CRSsNP)

This is an interventional treatment trial for Chronic Rhinosinusitis Without Nasal Polyps Read More

Inclusion Criteria:

• Part A only: Participant must be at least 18 years of age at the time of signing the informed consent form (ICF).

  • Part B only: Participant must be at least 12 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the 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 for CRS,

• Treatment with 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.

  • For Part B only: participants who have a blood eosinophil count ≥300 cells/mm3 at Screening
  • Body weight ≥30 kg.

Exclusion Criteria:

• Patients 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.
  • Patients 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.
  • Patients 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.
  • Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1.
  • Patients 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 patient 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.
  • Patients 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.