Chronic Rhinosinusitis With Nasal PolypsPhase 2NCT06454240
A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
A Phase 2 study testing lunsekimig in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 29 sites in 6 countries.
Trial summary
This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- lunsekimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 17 Jul 2024to 23 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening
- Ongoing symptoms for at least 2 months prior to screening, including:
- Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
- At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
- Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
- Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
- Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
- Active/chronic helminthic infection
- History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
- Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: 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
29 sites in 6 countries.
29 sites in 6 countries
United States14 sites
Emory University Hospital Midtown- Site Number : 8400012
Atlanta, Georgia, 30308
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017
Bellaire, Texas, 77401
The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002
Boise, Idaho, 83706
Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016
Boston, Massachusetts, 02115
Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004
Dallas, Texas, 75231
Allergy & Rheumatology- Site Number : 8400005
La Jolla, California, 92037
Berkson Medical - McKinney- Site Number : 8400014
McKinney, Texas, 75070
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008
Norfolk, Virginia, 23510
Advanced Research Institute - Odgen- Site Number : 8400022
Ogden, Utah, 84405
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003
Roseville, California, 95661
Alamo ENT Associates Site Number : 8400001
San Antonio, Texas, 78258
Senta Clinic- Site Number : 8400025
San Diego, California, 92018
James A Haley Veterans' Hospital- Site Number : 8400015
Tampa, Florida, 33612
Essential Medical Research- Site Number : 8400020
Tulsa, Oklahoma, 74137
Poland6 sites
Investigational Site Number : 6160003
Katowice, Silesian Voivodeship, 40-611
Investigational Site Number : 6160002
Krakow, Lesser Poland Voivodeship, 31-033
Investigational Site Number : 6160004
Poznan, 60-693
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, 00-909
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, 02-507
Investigational Site Number : 6160007
Wroclaw, 53-034
Argentina3 sites
Investigational Site Number : 0320001
Buenos Aires, 1121
Investigational Site Number : 0320003
Mendoza, 5500
Investigational Site Number : 0320002
Rosario, Santa Fe Province, 2000
United Kingdom3 sites
Investigational Site Number : 8260004
Gloucester, Gloucestershire, GL1 3NN
Investigational Site Number : 8260003
Manchester, M13 9WL
Investigational Site Number : 8260001
Newcastle upon Tyne, NE7 7DN
Belgium2 sites
Investigational Site Number : 0560002
Ghent, 9000
Investigational Site Number : 0560001
Leuven, 3000
About this study
Official title: A Randomized Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.
The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- lunsekimig, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lunsekimigDrug
Also called SAR443765
Pharmaceutical form:solution for injection-Route of administration:subcutaneous
placeboDrug
Pharmaceutical form:solution for injection-Route of administration:subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks. Receives: Drug: placebo |
| Arm 2 | Experimental | Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks. Receives: Drug: lunsekimig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bilateral endoscopic nasal polyp score (NPS).
This score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size where: 0- no polyps and 4- large polyps causing complete obstruction of the inferior nasal cavity.
Measured: From baseline to Week 24
Secondary outcomes (17)
Change in patient-reported nasal congestion/obstruction score
Patient-reported nasal congestion/obstruction score. Score is using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms
Measured: From baseline to Week 24
Change in Lund-Mackay CT score
Lund-Mackay system is based on scoring bilateral areas of opacification with points given for degree of sinus opacification in each reagion: 0 = normal, 1 = partial opacification, 2 = total opacification.
Measured: From baseline to Week 24
Change in the percent of maxillary sinus volume occupied by disease on CT scan.
Measured: From baseline to Week 24
Change in SNOT-22 total score.
The SNOT-22 is a 22-item health-related outcomes assessment. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
Measured: From baseline to Week 24
Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell).
Score is using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms
Measured: From baseline to Week 24
Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score
0-3 scale, component of patient-reported total symptom score
Measured: From baseline to Week 24
Change in rhinosinusitis visual analog scale (VAS).
The VAS for rhinosinusitis is used to evaluate the total severity (30). Rhinosinusitis disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm):
- MILD = VAS 0 to 3.
- MODERATE = VAS >3 to 7.
- SEVERE = VAS >7 to 10. The participant is asked to indicate along a 10 centimeter straight horizontal line (VAS) the answer to the question: "How troublesome are your symptoms of your rhinosinusitis". The VAS ranks from 0 (Not troublesome) to 10 (Worst thinkable troublesome) and is measured in centimeters.
Measured: From baseline to Week 24
Change in University of Pennsylvania Smell Identification Test (UPSIT) score.
The UPSIT test is a rapid and easy-to-administer method to quantitatively assess human olfactory function. The test consists of four booklets, each containing 10 odorants with one odorant per page. Above each odorant strip is a multiple-choice question with four alternative words to describe the odour. Score depends on the amount of answers out of 40 possible correct answers.
Measured: From baseline to Week 24
Change in patient-reported loss of smell score
0-3 scale, component of patient-reported total symptom score
Measured: From baseline to Week 24
Serum lunsekimig concentrations
Measured: From baseline to end of study (approximately 36 weeks)
Anti-drug antibodies (ADA) against lunsekimig
Measured: From baseline to end of study (approximately 36 weeks)
Incidence of participants with treatment-emergent adverse events (TEAEs)
Measured: From baseline to end of study (approximately 36 weeks)
Incidence of participants with adverse events of special interest (AESI)
Measured: From baseline to end of study (approximately 36 weeks)
Incidence of participants with serious adverse events (SAEs)
Measured: From baseline to end of study (approximately 36 weeks)
Change in asthma control questionnaire (ACQ-5)
ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control
Measured: From baseline to Week 24
Change in pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1)
Measured: From baseline to Week 24
Change in pre-BD percent predicted FEV1
Measured: From baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start17 Jul 2024
- Primary completion29 Jan 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454240
- Sponsor's protocol ID
- ACT18207
- Other IDs
- 2024-511261-11, U1111-1300-6978
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2024
- Last updated
- 28 Apr 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- ClinicalTrials.gov ID
- NCT06454240
- Acronym / sponsor ID
- ACT18207
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.
The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: placeboParticipant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks. |
| Arm 2 | Experimental | Drug: lunsekimigParticipant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening
- Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
- At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.
Key exclusion criteria (8 listed)
- Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
- Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
- Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
- Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
- Active/chronic helminthic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lunsekimigAlso: SAR443765Pharmaceutical form:solution for injection-Route of administration:subcutaneous | Drug | Arm 2 |
| placeboPharmaceutical form:solution for injection-Route of administration:subcutaneous | Drug | Arm 1 |
Primary outcome
Change in bilateral endoscopic nasal polyp score (NPS).
Time frame: From baseline to Week 24
This score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size where: 0- no polyps and 4- large polyps causing complete obstruction of the inferior nasal cavity.
17 secondary outcomes
Change in patient-reported nasal congestion/obstruction score
Time frame: From baseline to Week 24
Change in Lund-Mackay CT score
Time frame: From baseline to Week 24
Change in the percent of maxillary sinus volume occupied by disease on CT scan.
Time frame: From baseline to Week 24
Change in SNOT-22 total score.
Time frame: From baseline to Week 24
Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell).
Time frame: From baseline to Week 24
Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score
Time frame: From baseline to Week 24
Change in rhinosinusitis visual analog scale (VAS).
Time frame: From baseline to Week 24
Change in University of Pennsylvania Smell Identification Test (UPSIT) score.
Time frame: From baseline to Week 24
Change in patient-reported loss of smell score
Time frame: From baseline to Week 24
Serum lunsekimig concentrations
Time frame: From baseline to end of study (approximately 36 weeks)
Anti-drug antibodies (ADA) against lunsekimig
Time frame: From baseline to end of study (approximately 36 weeks)
Incidence of participants with treatment-emergent adverse events (TEAEs)
Time frame: From baseline to end of study (approximately 36 weeks)
Incidence of participants with adverse events of special interest (AESI)
Time frame: From baseline to end of study (approximately 36 weeks)
Incidence of participants with serious adverse events (SAEs)
Time frame: From baseline to end of study (approximately 36 weeks)
Change in asthma control questionnaire (ACQ-5)
Time frame: From baseline to Week 24
Change in pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1)
Time frame: From baseline to Week 24
Change in pre-BD percent predicted FEV1
Time frame: From baseline to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Chronic Rhinosinusitis with Nasal PolypsLink provided by the sponsor.
- ACT18207 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lunsekimig in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 29 sites in 6 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 4 inclusion and 8 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 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Poland, Argentina, United Kingdom, Belgium and 1 more country. 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 in bilateral endoscopic nasal polyp score (NPS). (time frame: From baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.