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Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)

NCT ID: NCT04684524

Last Updated: 2025-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2025-03-07

Brief Summary

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Primary Objective:

* To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS)

Secondary Objectives:

* To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24
* To assess the efficacy of dupilumab to reduce the need for rescue treatments
* To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS
* To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS
* To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS
* To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS
* To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses
* To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS
* To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS
* To characterize the effect of dupilumab on total IgE and specific IgE
* To assess immunogenicity to dupilumab in participants with AFRS

Detailed Description

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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.

Conditions

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Allergic Fungal Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dupilumab

Dupilumab administered every 2 or 4 weeks based on weights

Group Type EXPERIMENTAL

Dupilumab SAR231893

Intervention Type DRUG

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Matching placebo

Placebo administered every 2 or 4 weeks based on weights

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Interventions

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Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Intervention Type DRUG

Placebo

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Intervention Type DRUG

Eligibility Criteria

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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:

* hyperdensities
* bony demineralization
* bone erosion of sinus
* Eosinophilic mucin/mucus identified within 5 years prior to screening or at screening with or without positive fungal stain

AFRS patients with the following:

* An endoscopic NPS of at least 2 out of 4 for unilateral polyps or 3 out of 8 for bilateral polyps at Visit 1 (central reading) and Visit 2 (local reading) and,
* Sinus opacification in CT scan with an LMK score of 9 for patients with unilateral polyps or 12 for patients with bilateral polyps during screening period and,

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:

* 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. - 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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Asthma Allergy & Immunology Clinical Research Unit Site Number : 8400001

Tampa, Florida, United States

Site Status

Emory University Hospital Midtown Campus Site Number : 8400009

Atlanta, Georgia, United States

Site Status

Advanced ENT and Allergy Site Number : 8400004

Louisville, Kentucky, United States

Site Status

South Louisiana Ear, Nose, Throat and Facial Plastic Surgery Site Number : 8400019

Mandeville, Louisiana, United States

Site Status

National Allergy and Asthma Research, LLC Site Number : 8400002

Charleston, South Carolina, United States

Site Status

Vanderbilt University Medical Center Site Number : 8400013

Nashville, Tennessee, United States

Site Status

REX Clinical Trials Site Number : 8400017

Beaumont, Texas, United States

Site Status

Ut- Houston Medical School Site Number : 8400010

Houston, Texas, United States

Site Status

USA Clinical Trials Site Number : 8400020

San Antonio, Texas, United States

Site Status

Alamo ENT Associates Site Number : 8400018

San Antonio, Texas, United States

Site Status

Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400008

Norfolk, Virginia, United States

Site Status

Investigational Site Number : 0320003

CABA, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320001

CABA, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320005

Rosario, Santa Fe Province, Argentina

Site Status

Investigational Site Number : 0320002

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320004

Mendoza, , Argentina

Site Status

Investigational Site Number : 1240001

Vancouver, British Columbia, Canada

Site Status

Investigational Site Number : 1560005

Beijing, , China

Site Status

Investigational Site Number : 1560001

Beijing, , China

Site Status

Investigational Site Number : 1560004

Changsha, , China

Site Status

Investigational Site Number : 1560003

Chengdu, , China

Site Status

Investigational Site Number : 1560013

Fuzhou, , China

Site Status

Investigational Site Number : 1560006

Hangzhou, , China

Site Status

Investigational Site Number : 1560012

Hefei, , China

Site Status

Investigational Site Number : 1560002

Nanjing, , China

Site Status

Investigational Site Number : 1560011

Qingdao, , China

Site Status

Investigational Site Number : 1560009

Shanghai, , China

Site Status

Investigational Site Number : 1560008

Taiyuan, , China

Site Status

Investigational Site Number : 3560003

Coimbatore, , India

Site Status

Investigational Site Number : 3560006

Jodhpur, , India

Site Status

Investigational Site Number : 3560008

New Delhi, , India

Site Status

Investigational Site Number : 3760001

Petah Tikva, , Israel

Site Status

Investigational Site Number : 3760002

Rehovot, , Israel

Site Status

Investigational Site Number : 3920010

Isehara, Kanagawa, Japan

Site Status

Investigational Site Number : 3920006

Shizuoka, Shizuoka, Japan

Site Status

Investigational Site Number : 3920008

Bunkyo-ku, Tokyo, Japan

Site Status

Investigational Site Number : 3920001

Meguro-ku, Tokyo, Japan

Site Status

Investigational Site Number : 3920003

Shinagawa-ku, Tokyo, Japan

Site Status

Investigational Site Number : 3920009

Shinjuku-ku, Tokyo, Japan

Site Status

Investigational Site Number : 6820002

Riyadh, , Saudi Arabia

Site Status

Investigational Site Number : 6820001

Riyadh, , Saudi Arabia

Site Status

Investigational Site Number : 7920004

Adana, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920001

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920007

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920006

Izmir, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920003

Izmir, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920005

Malatya, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Canada China India Israel Japan Saudi Arabia Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://sanofi.trialsummaries.com/Study/StudyDetails?id=25253&tenant=MT_SNY_9011

EFC16724 Plain Language Results Summary

Other Identifiers

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U1111-1246-7549

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-002999-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC16724

Identifier Type: -

Identifier Source: org_study_id