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Chronic Rhinosinusitis Without Nasal PolypsPhase 2NCT06691113

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps

A Phase 2 study testing Itepekimab (SAR440340) and Mometasone furoate nasal spray (MFNS) in people with Chronic Rhinosinusitis Without Nasal Polyps, run by Sanofi at 57 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

ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo in male and female participants with chronic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Itepekimab (SAR440340) and Mometasone furoate nasal spray (MFNS)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
57 sitesin 13 countries
Study dates
16 Dec 2024to 12 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 18 years of age or older.
  • Participants must have ongoing symptoms of nasal congestion/obstruction at least 12 consecutive weeks before Visit 1 and a Nasal Congestion Score (NCS) ≥2 at Visit 1 (day score) and Visit 2 (weekly average score).
  • Participants must have sinus Total Symptom Score (sTSS) (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score).
  • Participants must have at least one of the following features:
  • Prior sinonasal surgery (as protocol defined) for chronic rhinosinusitis (CRS).
  • Treatment with systemic corticosteroid(s) (SCS) within the prior 2 years before Screening (Visit 1)
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  • Worsening symptoms of CRS in the past 2 years which would have required treatment with SCS, however participant is intolerant or has a contraindication to SCS.
  • Participants must have bilateral inflammation of paranasal sinuses with bilateral ethmoid and maxillary opacification on screening CT scan. Participants must have ≥25% opacification of the ethmoid sinuses and ≥25% opacification of at least 1 maxillary sinus by central reading of CT scan.
  • Participants must have a Sino-Nasal Outcome Test-22-Items (SNOT-22) score of ≥20 at Visit 1 and Visit 2.
  • Participants who have received a stable dose of mometasone furoate nasal spray (MFNS) for at least 3 weeks before Visit 2.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
  • Is not a women of childbearing potential (WOCBP). OR
  • Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study (at a minimum until 20 weeks after the last dose of study intervention).

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint.
  • Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil).
  • Radiological suspicion or confirmed invasive or expansive fungal rhinosinusitis.
  • Have any clinically significant diseases or disorders (eg, cardiovascular, pulmonary, gastrointestinal, liver, kidney, neurological, musculoskeletal, endocrine, metabolic, psychiatric, physical impairment) that, in the opinion of the Investigator, may put the subject at risk by participating in the study, or interfere with the subject's intervention, assessment, or influence the results of the study, or have compliance issues with the study.
  • Sinus surgery within 6 months before Screening (Visit 1)
Show all 11Show fewer
  • Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
  • Participants treated with other intranasal corticosteroid(s) (INCS) (only study provided AxMP [MFNS] is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as Xhance™ during the screening period.
  • Participants with a history of severe systemic hypersensitivity reaction to mAb.
  • Known allergy to itepekimab or to its excipients. Any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
  • 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

57 sites in 13 countries.

57 sites in 13 countries

United States10 sites

  • Allervie Clinical Research - Birmingham- Site Number : 8400006

    Birmingham, Alabama, 35209

  • Treasure Valley Medical Research- Site Number : 8400022

    Boise, Idaho, 83706

  • Modena Allergy + Asthma- Site Number : 8400005

    La Jolla, California, 92037

  • ENT Associates of Texas - McKinne- Site Number : 8400013

    McKinney, Texas, 75070

  • Advanced Research Associates (ARA) Professionals- Site Number : 8400002

    Miami, Florida, 33176

  • United Medical Doctors - Murrieta- Site Number : 8400001

    Murrieta, California, 92563

  • Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400007

    Norfolk, Virginia, 23510

  • Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008

    Roseville, California, 95661

  • Alamo ENT Associates- Site Number : 8400026

    San Antonio, Texas, 78258

  • Western States Clinical Research- Site Number : 8400009

    Wheat Ridge, Colorado, 80033

Other trials in United States

Canada6 sites

  • Investigational Site Number : 1240005

    London, Ontario, N6A 4V2

  • Investigational Site Number : 1240002

    Montreal, Quebec, H4A 3J1

  • Investigational Site Number : 1240001

    Québec, Quebec, G1V 4G5

  • Investigational Site Number : 1240003

    Québec, Quebec, G1V 4W2

  • Investigational Site Number : 1240012

    Québec, Quebec, G2J 0C4

  • Investigational Site Number : 1240009

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

Spain6 sites

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona], 08003

  • Investigational Site Number : 7240004

    Jerez de la Frontera, Cádiz, 11407

  • Investigational Site Number : 7240002

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907

  • Investigational Site Number : 7240006

    Madrid, 28040

  • Investigational Site Number : 7240005

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240001

    Seville, Sevilla, 41009

Other trials in Spain

Poland5 sites

  • Investigational Site Number : 6160004

    Bielsko-Biala, Silesian Voivodeship, 43-300

  • Investigational Site Number : 6160006

    Krakow, Lesser Poland Voivodeship, 31-513

  • Investigational Site Number : 6160008

    Lodz, Lódzkie, 90-302

  • Investigational Site Number : 6160002

    Poznan, Greater Poland Voivodeship, 60-693

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 00-909

Other trials in Poland

South Korea5 sites

  • Investigational Site Number : 4100005

    Cheonan-si, Chungcheongnam-do, 31116

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 06351

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 07061

Other trials in South Korea

Belgium4 sites

  • Investigational Site Number : 0560003

    Brussels, 1200

  • Investigational Site Number : 0560004

    Gesves, 5340

  • Investigational Site Number : 0560002

    Ghent, 9000

  • Investigational Site Number : 0560001

    Leuven, 3000

Other trials in Belgium

China4 sites

  • Investigational Site Number : 1560004

    Baotou, 014040

  • Investigational Site Number : 1560001

    Beijing, 100730

  • Investigational Site Number : 1560002

    Shanghai, 200127

  • Investigational Site Number : 1560003

    Zibo, 255036

Other trials in China

France4 sites

  • Investigational Site Number : 2500012

    La Rochelle, 17019

  • Investigational Site Number : 2500004

    Marseille, 13005

  • Investigational Site Number : 2500005

    Montpellier, 34295

  • Investigational Site Number : 2500010

    Poitiers, 86021

Other trials in France

Argentina3 sites

  • Investigational Site Number : 0320001

    Buenos Aires, 1425

  • Investigational Site Number : 0320004

    Corrientes, 3400

  • Investigational Site Number : 0320003

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Chile3 sites

  • Investigational Site Number : 1520002

    Concepción, Biobio, 4070094

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500692

Other trials in Chile

Italy3 sites

  • Azienda Ospedaliero-Universitaria Pisana-Site Number : 3800003

    Pisa, 56124

  • Fondazione Policlinico Universitario Campus Bio-Medico-Site Number : 3800002

    Rome, Roma, 00128

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001

    Rome, Roma, 00168

Other trials in Italy

Portugal2 sites

  • Investigational Site Number : 6200001

    Guimarães, 4800-055

  • Investigational Site Number : 6200002

    Porto, 3814-501

Other trials in Portugal

Romania2 sites

  • Investigational Site Number : 6420001

    Brasov, 500283

  • Investigational Site Number : 6420002

    Bucharest, 022328

Other trials in Romania

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab in Participants With Inadequately Controlled Chronic Rhinosinusitis Without Nasal Polyps

ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older.

Study details include:

  • The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks.
  • The intervention duration will be 24 weeks.
  • The number of visits will be 7 site visits and 8 phone/remote visits.
Being tested
Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray (MFNS)

What participants receive

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

  • Itepekimab (SAR440340)Drug

    Also called REGN3500

    Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

  • Mometasone furoate nasal spray (MFNS)Drug

    Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray

Study groups in NCT06691113
Study groupRoleWhat they receive
Itepekimab high doseExperimentalSubcutaneous (SC) administration of Itepekimab high dose for 24 weeks
Receives: Drug: Itepekimab (SAR440340); Drug: Mometasone furoate nasal spray (MFNS)
Itepekimab low doseExperimentalSC administration of Itepekimab low dose for 24 weeks
Receives: Drug: Itepekimab (SAR440340); Drug: Placebo; Drug: Mometasone furoate nasal spray (MFNS)
PlaceboPlacebo comparatorSC administration of matching placebo for 24 weeks
Receives: Drug: Placebo; Drug: Mometasone furoate nasal spray (MFNS)

What is being measured

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

  1. Change from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan

    Change from baseline in sinus inflammation as assessed by Computerized Tomography (CT) scan of the sinuses in the itepekimab-- compared to placebo-- treated study participants on the background of intranasal corticosteroid (INCS).

    Measured: Baseline to End of Treatment (EOT) (Week 24)

Secondary outcomes (10)

  1. Change from baseline in the sTSS

    The CRSsNP sinus Total Symptom Score (sTSS) is a composite score derived from nasal congestion (NC), anterior/posterior rhinorrhea, and facial pain/pressure. The total score ranges from 0 to 9 with higher scores indicating greater overall symptom severity.

    Measured: Baseline to EOT (Week 24)

  2. Change from baseline in nasal congestion (NC) severity score using the CRSsNP daily ediary

    The CRSsNP sinonasal symptom diary is designed to assess the severity of CRS sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity.

    Measured: Baseline to EOT (Week 24)

  3. Change from baseline in anterior/posterior rhinorrhea severity score using the CRSsNP daily ediary

    The CRSsNP sinonasal symptom diary is designed to assess the severity of CRS sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity.

    Measured: Baseline to EOT (Week 24)

  4. Change from baseline in facial pain/pressure severity score using the CRSsNP daily ediary

    The CRSsNP sinonasal symptom diary is designed to assess the severity of CRS sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity.

    Measured: Baseline to EOT (Week 24)

  5. Change from baseline in loss of smell severity score using the CRSsNP daily ediary

    The CRSsNP sinonasal symptom diary is designed to assess the severity of CRS sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity.

    Measured: Baseline to EOT (Week 24)

  6. Change from baseline in SNOT-22 total score

    The Sino-Nasal Outcome Test-22-Items (SNOT-22) is a patient-reported outcome questionnaire designed to assess the impact of chronic rhinosinusitis (CRS) on patients' Health-Related Quality of Life (HRQoL). It has 22 items covering symptoms, social/emotional impact, productivity, and sleep consequences of CRS. A global score ranges from 0 to 110 with higher score indicating greater rhinosinusitis-related health burden.

    Measured: Baseline to EOT (Week 24)

  7. Change from baseline in sinus opacification as measured by the Lund-Mackay (LMK) score and the modified LMK score

    The LMK and the modified LMK scoring systems are based on points given for degree of opacification, which are applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The osteomeatal complex is graded as 0 = not occluded, or 2 = occluded, deriving a maximum score of 12 per side.

    Measured: Baseline to EOT (Week 24)

  8. Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment emergent serious adverse events (TESAEs), and TEAEs leading to intervention discontinuation

    Measured: Baseline up to End of Study (EOS) (Week 44)

  9. Itepekimab concentration in serum

    Measured: Baseline to EOS (Week 44)

  10. Incidence of treatment-emergent (TE) anti-itepekimab antibodies responses

    Measured: Baseline to EOS (Week 44)

Timeline

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

  1. First posted15 Nov 2024
  2. Study start16 Dec 2024
  3. Primary completion31 Mar 2026
  4. Study completion12 Aug 2026

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
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06691113
Sponsor's protocol ID
ACT18421
Other IDs
2024-515576-12, U1111-1306-6643
Status last verified
Aug 2026
First submitted
12 Nov 2024
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
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 Itepekimab (SAR440340) and Mometasone furoate nasal spray (MFNS) in people with Chronic Rhinosinusitis Without Nasal Polyps, run by Sanofi at 57 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 13 inclusion and 11 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Canada, Spain, Poland, South Korea 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan (time frame: Baseline to End of Treatment (EOT) (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 NCT06691113.

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 25 Aug 2026.

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