Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
Primary Objective:
Secondary Objectives:
Full description
The duration of study for each participant will include 2-4 weeks of screening period (2 additional weeks could be allowed), 52 weeks of randomized investigational medicinal product (IMP) intervention period and 12 weeks of follow-up period.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Participant must be at least 6 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the informed consent.
Participants with the diagnosis of AFRS adapted from criteria by Bent and Kuhn (meeting all):
IgE mediated inflammatory response to fungal hyphae (specific IgE serology or skin test) Evidence of sensitization to fungus by skin testing (at screening or documented historical positive skin test in the previous 12 months), or positive fungal-specific IgE in serum at screening.
Nasal polyposis confirmed by nasal endoscopy at screening.
Characteristic CT signs to be performed during screening period and can include any of the below signs as assessed by central reader:
Eosinophilic mucin/mucus identified within 5 years prior to screening or at screening with or without positive fungal stain
AFRS patients with the following:
Body weight ≥15 kg
Exclusion criteria
Patients with nasal conditions/concomitant nasal diseases making them non-evaluable at Visit 1 or for the primary efficacy
Nasal cavity malignant tumor and benign tumors.
Known of fungal invasion into sinus tissue.
Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's 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
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.
Treatment with commercially available dupilumab within 12 months, participation in prior dupilumab clinical trial, or 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.
Patients who are on intranasal corticosteroids (INCS) spray unless they have received stable dose for at least 4 weeks prior to Visit 1.
Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1.
Patients who have taken:
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. - 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.
Primary purpose
Allocation
Interventional model
Masking
62 participants in 2 patient groups, including a placebo group
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Central trial contact
Trial Transparency email recommended (Toll free number for US & Canada)
Data sourced from clinicaltrials.gov
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