Chronic Rhinosinusitis With Nasal PolypsPhase 2ENSEMBLENCT06914908
Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
A Phase 2 study testing Lunsekimig and Mometasone furoate nasal spray (MFNS) in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 24 sites in 6 countries.
Trial summary
This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Lunsekimig and Mometasone furoate nasal spray (MFNS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 12 May 2025to 22 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol
- Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS)
- Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
- 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
24 sites in 6 countries.
24 sites in 6 countries
United States9 sites
Treasure Valley Medical Research- Site Number : 8400002
Boise, Idaho, 83706
Pharmaceutical Research & Consulting- Site Number : 8400004
Dallas, Texas, 75231
The University of Texas Health Science Center- Site Number : 8400017
Houston, Texas, 77030
Orso Health- Site Number : 8400005
La Jolla, California, 92037
ENT Associates of Texas - McKinney- Site Number : 8400014
McKinney, Texas, 75070
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008
Norfolk, Virginia, 23510
Capital Allergy & Respiratory Disease Center- Site Number : 8400003
Roseville, California, 95661
Alamo ENT Associates- Site Number : 8400001
San Antonio, Texas, 78258
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, 30-033
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, 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, Lower Silesian Voivodeship, 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 Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207).
The study duration will be up to approximately 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Lunsekimig, Mometasone furoate nasal spray (MFNS)
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
Mometasone furoate nasal spray (MFNS)Drug
- Pharmaceutical form: Solution for administration via spray pump
- Route of administration: intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| Lunsekimig | Experimental | Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks Receives: Drug: Lunsekimig; Drug: Mometasone furoate nasal spray (MFNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs)
Measured: From baseline to Week 148
Secondary outcomes (5)
Change in Sino-nasal Outcome Test 22 (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 the parent study baseline to Weeks 52, 96 and 144
Change in Rhinosinusitis visual analog scale (VAS)
The VAS for rhinosinusitis is used to evaluate the total severity. 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 the parent study baseline to Weeks 52, 96 and 144
Change in The 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 odor. Score depends on the amount of answers out of 40 possible correct answers.
Measured: From the parent study baseline to Weeks 52, 96 and 144
Serum lunsekimig concentrations
Measured: From baseline to Week 144
Anti-drug antibodies (ADA) against lunsekimig
Measured: From baseline to Week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2025
- Study start12 May 2025
- Primary completion22 Feb 2029 (estimated)
- Study completion22 Feb 2029 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914908
- Sponsor's protocol ID
- LTS18300
- Other IDs
- 2024-515912-27, U1111-1308-9807
- Acronym
- ENSEMBLE
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2025
- Last updated
- 28 Oct 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
- ClinicalTrials.gov ID
- NCT06914908
- Acronym / sponsor ID
- ENSEMBLE / LTS18300
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 22 Feb 2029 (estimated)
- Study completion
- 22 Feb 2029 (estimated)
- First posted
- 7 Apr 2025 (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 single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207).
The study duration will be up to approximately 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lunsekimig | Experimental | Drug: Lunsekimig, Drug: Mometasone furoate nasal spray (MFNS)Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol
- Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS)
- Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures
Key exclusion criteria (4 listed)
- Prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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: SAR443765* Pharmaceutical form: solution for injection * Route of administration: subcutaneous | Drug | Lunsekimig |
| Mometasone furoate nasal spray (MFNS)* Pharmaceutical form: Solution for administration via spray pump * Route of administration: intranasal spray | Drug | Lunsekimig |
Primary outcome
Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs)
Time frame: From baseline to Week 148
5 secondary outcomes
Change in Sino-nasal Outcome Test 22 (SNOT-22) total score
Time frame: From the parent study baseline to Weeks 52, 96 and 144
Change in Rhinosinusitis visual analog scale (VAS)
Time frame: From the parent study baseline to Weeks 52, 96 and 144
Change in The University of Pennsylvania Smell Identification Test (UPSIT) score
Time frame: From the parent study baseline to Weeks 52, 96 and 144
Serum lunsekimig concentrations
Time frame: From baseline to Week 144
Anti-drug antibodies (ADA) against lunsekimig
Time frame: From baseline to Week 144
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- LTS18300 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.
24 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 and Mometasone furoate nasal spray (MFNS) in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 24 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs) (time frame: From baseline to Week 148). 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 Oct 2026.