Dupilumab in CRSsNP

NCT ID: NCT04678856

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2024-01-29

Brief Summary

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

Detailed Description

The duration of study for each participant will include 2-4 weeks of screening period, 24-52 weeks randomized investigational medicinal product (IMP) intervention period and 12 weeks of follow-up period.

Conditions

Chronic Rhinosinusitis Without Nasal Polyps; Sinusitis; Chronic Sinusitis; Sinus Disorder; Respiratory Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A and B: Dupilumab

Participants received dupilumab 300 milligrams (mg) via SC injection q2w for up to 53.1 weeks.

Group Type: EXPERIMENTAL

Dupilumab SAR231893

Intervention Type: DRUG

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Part A and B: Matching placebo

Participants received matching placebo via SC injection q2w for up to 53.2 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Interventions

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

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sacramento Ear, Nose & Throat Site Number : 8400010

Roseville, California, United States

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

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560001

Beijing, , China

Investigational Site Number : 1560005

Changchun, , China

Investigational Site Number : 1560013

Changsha, , China

Investigational Site Number : 1560010

Chongqing, , China

Investigational Site Number : 1560006

Shanghai, , China

Investigational Site Number : 1560008

Yantai, , China

Investigational Site Number : 3480004

Budapest, , Hungary

Investigational Site Number : 3480001

Pécs, , Hungary

Investigational Site Number : 6200002

Aveiro, , Portugal

Investigational Site Number : 6200001

Guimarães, , Portugal

Investigational Site Number : 6200003

Matosinhos Municipality, , Portugal

Investigational Site Number : 6430005

Moscow, , Russia

Investigational Site Number : 6430002

Saint Petersburg, , Russia

Investigational Site Number : 6430003

Saint Petersburg, , Russia

Investigational Site Number : 6430001

Stavropol, , Russia

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240002

Seville, Andalusia, Spain

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240007

Santander, Cantabria, Spain

Investigational Site Number : 7240004

Jerez de la Frontera, Cádiz, Spain

Investigational Site Number : 7240009

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240005

Madrid / Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240008

Pamplona, Navarre, Spain

Investigational Site Number : 7240010

Madrid, , Spain

Investigational Site Number : 7520001

Stockholm, , Sweden

Investigational Site Number : 8040005

Dnipro, , Ukraine

Investigational Site Number : 8040001

Ivano-Frankivsk, , Ukraine

Investigational Site Number : 8040004

Kharkiv, , Ukraine

Investigational Site Number : 8040008

Kyiv, , Ukraine

Investigational Site Number : 8040002

Kyiv, , Ukraine

Investigational Site Number : 8040007

Kyiv, , Ukraine

Countries

United States; Argentina; Belgium; Canada; Chile; China; Hungary; Portugal; Russia; South Korea; Spain; Sweden; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://sanofi.trialsummaries.com/Study/StudyDetails?id=25252&tenant=MT_SNY_9011

EFC16723 Plain language Results Summary

Other Identifiers

U1111-1246-7522

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-003117-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC16723

Identifier Type: -

Identifier Source: org_study_id