A Phase 2 interventional study of Dupilumab SAR231893 and Placebo in Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis and Chronic Sinusitis, sponsored by Sanofi. Completed at 58 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
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:
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.
256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.
This study's enrollment of 71 is above the median of 60 across 196 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must have one of the 2 following features:
Exclusion Criteria:
Participants who have taken:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received dupilumab 300 milligrams (mg) via SC injection q2w for up to 53.1 weeks.
Drug: Dupilumab SAR231893
Participants received matching placebo via SC injection q2w for up to 53.2 weeks.
Drug: Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
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.
Time frame: Baseline (Day 1) and Week 24
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.
Time frame: Baseline (Day 1) and Week 24
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.
Time frame: Baseline (Day 1) and Week 24
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.
Time frame: 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
Serum Concentration of Dupilumab Over Time
Blood samples were collected at the specified timepoints to evaluate serum concentration of dupilumab.
Time frame: Baseline (Day 1) and Weeks 12, 24 and 52
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.
Time frame: Baseline (Day 1) and up to Week 52
The study was conducted at 57 centers in 13 countries. A total of 269 participants were screened between 02 December 2020 to 26 April 2023, of which 198 participants were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
| Milestone | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Started | 33 | 38 |
| Completed | 25 | 37 |
| Not completed | 8 | 1 |
| Withdrew: Not related to coronavirus disease-2019 (covid-19) | 3 | 0 |
| Withdrew: Withdrawal by subject | 5 | 1 |
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.
| Score on a scale | Dupilumab 300 mg q2w |
|---|---|
| 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 | -6.63 ± 3.91 |
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.
| Score on a scale | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score | -0.68 ± 2.26 | -6.63 ± 3.91 |
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.
| Score on a scale | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Change From Baseline to Week 24 in Sinus Total Symptom Score (sTSS) | -1.75 ± 2.19 | -3.18 ± 2.68 |
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.
| Participants | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| TEAEs | 27 | 29 |
| TESAEs | 6 | 3 |
| TEAEs leading to treatment discontinuation | 0 | 1 |
Blood samples were collected at the specified timepoints to evaluate serum concentration of dupilumab.
| Nanograms per milliliter | Dupilumab 300 mg q2w |
|---|---|
| Baseline | 0.00 ± 0.00 |
| Week 12 | 54733.20 ± 26222.53 |
| Week 24 | 62192.86 ± 23979.23 |
| Week 52 | 68365.00 ± 30613.86 |
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.
| Participants | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Pre-existing immunoreactivity | 1 | 0 |
| Treatment-emergent ADA response | 1 | 1 |
| Treatment-boosted ADA response | 1 | 0 |
| Positive Nab | 3 | 1 |
Collected over TEAEs and TESAEs were collected 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. All-cause mortality (deaths) were collected from participant's screening (Day -28) to the end of follow-up for each participant, up to 476 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/33 (0%) | 6/33 (18.2%) | 12/33 (36.4%) |
| Dupilumab 300 mg q2w | 0/38 (0%) | 3/38 (7.9%) | 20/38 (52.6%) |
| Event | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Chronic SinusitisInfections and infestations | 1/33 | 0/38 |
| Foot DeformityMusculoskeletal and connective tissue disorders | 1/33 | 0/38 |
| Spinal OsteoarthritisMusculoskeletal and connective tissue disorders | 1/33 | 0/38 |
| Diabetic NeuropathyNervous system disorders | 1/33 | 0/38 |
| SyncopeNervous system disorders | 1/33 | 0/38 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/33 | 0/38 |
| Peripheral Arterial Occlusive DiseaseVascular disorders | 1/33 | 0/38 |
| Myocardial BridgingCongenital, familial and genetic disorders | 0/33 | 1/38 |
| Chronic GastritisGastrointestinal disorders | 0/33 | 1/38 |
| BilomaHepatobiliary disorders | 0/33 | 1/38 |
| Event | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Covid-19Infections and infestations | 7/33 | 8/38 |
| Injection Site ErythemaGeneral disorders | 1/33 | 4/38 |
| Upper Respiratory Tract InfectionInfections and infestations | 3/33 | 0/38 |
| Accidental OverdoseInjury, poisoning and procedural complications | 3/33 | 2/38 |
| Injection Site ReactionGeneral disorders | 1/33 | 3/38 |
| Injection Site SwellingGeneral disorders | 2/33 | 0/38 |
| NasopharyngitisInfections and infestations | 2/33 | 2/38 |
| Viral Upper Respiratory Tract InfectionInfections and infestations | 2/33 | 2/38 |
| FallInjury, poisoning and procedural complications | 2/33 | 1/38 |
| HeadacheNervous system disorders | 2/33 | 2/38 |
Randomized population included all participants with a treatment kit number allocated and recorded in the interactive response technology (IRT) database, and regardless of whether the treatment kit was used or not.
| Age, Continuous(Years) | Placebo | Dupilumab 300 mg q2w | Total |
|---|---|---|---|
| Mean | 47.45 ± 17.46 | 46.45 ± 12.60 | 46.92 ± 14.95 |
| Sex: Female, Male(Participants) | Placebo | Dupilumab 300 mg q2w | Total |
|---|---|---|---|
| Female | 16 | 25 | 41 |
| Male | 17 | 13 | 30 |
| Race (NIH/OMB)(Participants) | Placebo | Dupilumab 300 mg q2w | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 30 | 31 | 61 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Lund-Mackay (LMK) Score(Score on a scale) | Placebo | Dupilumab 300 mg q2w | Total |
|---|---|---|---|
| Mean | 11.50 ± 3.19 | 11.41 ± 3.69 | 11.45 ± 3.44 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Ran from Dec 2020 to primary completion in Nov 2023, 35 months.
Results were first posted in Dec 2024, 1 year 1 month after primary completion.
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Studies of the drug tested here: Dupilumab