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Chronic Rhinosinusitis Without Nasal PolypsPhase 2Liberty CRSsNPNCT04678856

Dupilumab in CRSsNP

A Phase 2 study testing Dupilumab SAR231893 in people with Chronic Rhinosinusitis Without Nasal Polyps and Sinusitis, run by Sanofi at 58 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dupilumab SAR231893
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
58 sitesin 13 countries
Study dates
2 Dec 2020to 29 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

58 sites in 13 countries.

58 sites in 13 countries

United States11 sites

  • University of Missouri Health System Site Number : 8400016

    Columbia, Missouri, 65212

  • Optimed Research, LTD Site Number : 8400017

    Columbus, Ohio, 43235

  • Pharmaceutical Research & Consulting, Inc. Site Number : 8400006

    Dallas, Texas, 75231

  • Colorado Allergy and Asthma Centers, PC Site Number : 8400003

    Denver, Colorado, 80230

  • Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400009

    Norfolk, Virginia, 23507

  • Nebraska Medical Research Institute Site Number : 8400007

    Papillion, Nebraska, 68046

  • Sacramento Ear, Nose & Throat Site Number : 8400010

    Roseville, California, 95661

  • Alamo ENT Associates Site Number : 8400021

    San Antonio, Texas, 78258

  • Bensch Clinical Research LLC Site Number : 8400015

    Stockton, California, 95207

  • Vital Prospects Clinical Research Institute, P.C. Site Number : 8400004

    Tulsa, Oklahoma, 74136

  • Essential Medical Research, LLC Site Number : 8400014

    Tulsa, Oklahoma, 74137

Other trials in United States

Canada9 sites

  • Investigational Site Number : 1240010

    Hamilton, Ontario, L8L 2X2

  • Investigational Site Number : 1240007

    Kingston, Ontario, K7L 2V7

  • Investigational Site Number : 1240016

    London, Ontario, N6A 4V2

  • Investigational Site Number : 1240001

    Montreal, Quebec, H2X 3E4

  • Investigational Site Number : 1240012

    Montreal, Quebec, H4A 3J1

  • Investigational Site Number : 1240005

    Québec, G1V 4G5

  • Investigational Site Number : 1240003

    Québec, G1V 4W2

  • Investigational Site Number : 1240002

    Trois-Rivières, Quebec, G8T 7A1

  • Investigational Site Number : 1240013

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Spain8 sites

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08036

  • Investigational Site Number : 7240004

    Jerez de la Frontera, Cádiz, 11407

  • Investigational Site Number : 7240009

    Madrid, Madrid, Comunidad de, 28027

  • Investigational Site Number : 7240010

    Madrid, 28034

  • Investigational Site Number : 7240005

    Madrid / Madrid, Madrid, Comunidad de, 28040

  • Investigational Site Number : 7240008

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240007

    Santander, Cantabria, 39008

  • Investigational Site Number : 7240002

    Seville, Andalusia, 41009

Other trials in Spain

China6 sites

  • Investigational Site Number : 1560001

    Beijing, 100730

  • Investigational Site Number : 1560005

    Changchun, 130021

  • Investigational Site Number : 1560013

    Changsha, 410013

  • Investigational Site Number : 1560010

    Chongqing, 400016

  • Investigational Site Number : 1560006

    Shanghai, 200065

  • Investigational Site Number : 1560008

    Yantai, 264000

Other trials in China

Ukraine6 sites

  • Investigational Site Number : 8040005

    Dnipro, 49006

  • Investigational Site Number : 8040001

    Ivano-Frankivsk, 76018

  • Investigational Site Number : 8040004

    Kharkiv, 61166

  • Investigational Site Number : 8040008

    Kyiv, 01033

  • Investigational Site Number : 8040002

    Kyiv, 03680

  • Investigational Site Number : 8040007

    Kyiv, 04050

Other trials in Ukraine

Russia4 sites

  • Investigational Site Number : 6430005

    Moscow, 121359

  • Investigational Site Number : 6430002

    Saint Petersburg, 197022

  • Investigational Site Number : 6430003

    Saint Petersburg, 197022

  • Investigational Site Number : 6430001

    Stavropol, 355020

Other trials in Russia

Argentina3 sites

  • Investigational Site Number : 0320002

    Buenos Aires, C1121ABE

  • Investigational Site Number : 0320003

    Ciudad Autonoma Buenos Aires, C1414AIF

  • Investigational Site Number : 0320001

    Ciudad Autonoma Buenos Aires, C1425BEN

Other trials in Argentina

Portugal3 sites

  • Investigational Site Number : 6200002

    Aveiro, 3810-501

  • Investigational Site Number : 6200001

    Guimarães, 4810-061

  • Investigational Site Number : 6200003

    Matosinhos Municipality, 4464-513

Other trials in Portugal

Belgium2 sites

  • Investigational Site Number : 0560002

    Ghent, 9000

  • Investigational Site Number : 0560001

    Leuven, 3000

Other trials in Belgium

Hungary2 sites

  • Investigational Site Number : 3480004

    Budapest, 1115

  • Investigational Site Number : 3480001

    Pécs, 7621

Other trials in Hungary

South Korea2 sites

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 07061

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 135-710

Other trials in South Korea

Chile1 site

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8207257

Other trials in Chile

Sweden1 site

  • Investigational Site Number : 7520001

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP)

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
Read the 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.

Being tested
Dupilumab SAR231893, Placebo
Medical subject headings
Sinusitis, Paranasal Sinus Diseases, Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dupilumab SAR231893Drug

    Pharmaceutical form:Injection solution Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Study groups in NCT04678856
Study groupRoleWhat they receive
Part A and B: DupilumabExperimentalParticipants received dupilumab 300 milligrams (mg) via SC injection q2w for up to 53.1 weeks.
Receives: Drug: Dupilumab SAR231893
Part A and B: Matching placeboPlacebo comparatorParticipants received matching placebo via SC injection q2w for up to 53.2 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 24 in Opacification of Sinuses Assessed by Computed Tomography (CT) Scan Using the Lund Mackay (LMK) Score in Dupilumab Group

    The CT scan LMK staging system represented the most widely established method of sinus CT scoring. The LMK total score is based on assessment of the CT scan findings for each sinus area (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus on each side). The extent of mucosal opacification is rated on a 3-point scale ranging from 0 = normal to 2 = total opacification. In addition, the ostiomeatal complex is graded as 0 = not occluded or 2 = occluded. The maximum score is therefore 12 per side; total score ranges from 0 (normal) to 24 (more opacified), corresponding to the sum of all sinuses and the ostiomeatal unit. Higher score indicated worse outcome. Baseline was defined as the last available value up to randomization date and prior to the first dose of study medication.

    Measured: Baseline (Day 1) and Week 24

Secondary outcomes (5)

  1. Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score

    The CT scan LMK staging system represented the most widely established method of sinus CT scoring. The LMK total score is based on assessment of the CT scan findings for each sinus area (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus on each side). The extent of mucosal opacification is rated on a 3-point scale ranging from 0 = normal to 2 = total opacification. In addition, the ostiomeatal complex is graded as 0 = not occluded or 2 = occluded. The maximum score is therefore 12 per side; total score ranges from 0 (normal) to 24 (more opacified), corresponding to the sum of all sinuses and the ostiomeatal unit. Higher score indicated worse outcome. Baseline was defined as the last available value up to randomization date and prior to the first dose of study medication.

    Measured: Baseline (Day 1) and Week 24

  2. Change From Baseline to Week 24 in Sinus Total Symptom Score (sTSS)

    The sTSS is a composite score derived from the following individual items: nasal congestion (NC), anterior/posterior rhinorrhea, and facial pain/pressure. Each of the individual items were scored from 0 (no symptoms) to 3 (severe symptoms). The total score ranges from 0 to 9 and consists of the sum of NC, the averaged rhinorrhea item scores, and facial pain/pressure scores. Higher scores on sTSS indicated greater overall symptom severity. Baseline was defined as the last available value up to randomization date and prior to the first dose of study medication.

    Measured: Baseline (Day 1) and Week 24

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs (TESAEs), and TEAEs Leading to Treatment Discontinuation

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

    Measured: From the first dose of study drug (Day 1) up to the last dose of study drug administration (373 days) + 98 days, up to 471 days

  4. Serum Concentration of Dupilumab Over Time

    Blood samples were collected at the specified timepoints to evaluate serum concentration of dupilumab.

    Measured: Baseline (Day 1) and Weeks 12, 24 and 52

  5. Number of Participants With Antidrug Antibody (ADA) Response to Dupilumab and Positive Neutralizing Antibody (Nab)

    Plasma samples were collected to evaluate antibodies to dupilumab. Pre-existing immunoreactivity was defined as an ADA positive response in the assay at baseline with all post first dose ADA results negative, OR an ADA positive response at baseline with all post first dose ADA responses less than 4-fold over baseline titer levels. Treatment-emergent ADA responses were defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing. Treatment-boosted response was defined as an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. Samples positive in the ADA assay were further characterized for the presence of NAbs.

    Measured: Baseline (Day 1) and up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2020
  2. Study start2 Dec 2020
  3. Primary completion14 Nov 2023
  4. Study completion29 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04678856
Sponsor's protocol ID
EFC16723
Other IDs
U1111-1246-7522, 2020-003117-35
Acronym
Liberty CRSsNP
Status last verified
Jul 2026
First submitted
16 Dec 2020
Last updated
30 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dupilumab SAR231893 in people with Chronic Rhinosinusitis Without Nasal Polyps and Sinusitis, run by Sanofi at 58 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada, Spain, China, Ukraine and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 24 in Opacification of Sinuses Assessed by Computed Tomography (CT) Scan Using the Lund Mackay (LMK) Score in Dupilumab Group (time frame: Baseline (Day 1) and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04678856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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