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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06834360




Registration number
NCT06834360
Ethics application status
Date submitted
14/02/2025
Date registered
19/02/2025

Titles & IDs
Public title
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Secondary ID [1] 0 0
2024-516815-26
Secondary ID [2] 0 0
EFC18419
Universal Trial Number (UTN)
Trial acronym
CEREN2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis With Nasal Polyps 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Itepekimab (SAR440340)
Treatment: Drugs - Placebo
Treatment: Drugs - Mometasone furoate nasal spray (MFNS)

Experimental: Itepekimab high dose - Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks

Experimental: Itepekimab low dose - SC administration of Itepekimab low dose for 52 weeks

Placebo comparator: Placebo - SC administration of matching placebo for 52 weeks


Treatment: Drugs: Itepekimab (SAR440340)
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

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

Treatment: Drugs: Mometasone furoate nasal spray (MFNS)
Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in the endoscopic NPS
Timepoint [1] 0 0
Baseline to Week 24
Primary outcome [2] 0 0
Change from baseline in the NCS
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Change from baseline in endoscopic NPS
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Change from baseline in NCS
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Change from baseline in opacification of sinuses assessed by Computed Tomography (CT) scan using the LMK score
Timepoint [3] 0 0
Baseline to Week 24
Secondary outcome [4] 0 0
Change from baseline in the TSS (nasal congestion/obstruction, anterior/posterior rhinorrhea, and loss of sense of smell)
Timepoint [4] 0 0
Baseline to Weeks 24 and 52
Secondary outcome [5] 0 0
Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary, and UPSIT score
Timepoint [5] 0 0
Baseline to Weeks 24 and 52
Secondary outcome [6] 0 0
Change from baseline in SNOT-22 total score
Timepoint [6] 0 0
Baseline to Weeks 24 and 52
Secondary outcome [7] 0 0
Change from baseline in PROMIS SD-SF-8b scores
Timepoint [7] 0 0
Baseline to Weeks 24 and 52
Secondary outcome [8] 0 0
Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for CRS
Timepoint [8] 0 0
Baseline up to Week 52
Secondary outcome [9] 0 0
Annualized rate of SCS course or surgery for CRS
Timepoint [9] 0 0
Baseline up to Week 52
Secondary outcome [10] 0 0
Time to first either SCS or surgery for CRS
Timepoint [10] 0 0
Baseline through Week 52
Secondary outcome [11] 0 0
Change from baseline in pre-BD FEV1 (in mL) in participants with co-morbid asthma
Timepoint [11] 0 0
Baseline to Weeks 24 and 52
Secondary outcome [12] 0 0
Change from baseline in ACQ-5 score in participants with co-morbid asthma
Timepoint [12] 0 0
Baseline to Weeks 24 and 52
Secondary outcome [13] 0 0
Change from the baseline in NPS and NCS in the subgroup of patients with aspirin-exacerbated respiratory disease (AERD)
Timepoint [13] 0 0
Baseline to Weeks 24 and 52
Secondary outcome [14] 0 0
Proportion of participants with AERD requiring SCS or surgery for CRS
Timepoint [14] 0 0
Baseline up to Week 52
Secondary outcome [15] 0 0
Annualized rate of SCS course or surgery for CRS in participants with AERD
Timepoint [15] 0 0
Baseline up to Week 52
Secondary outcome [16] 0 0
Time to first either SCS or surgery for CRS in participants with AERD
Timepoint [16] 0 0
Baseline through Week 52
Secondary outcome [17] 0 0
Change from baseline in pre-BD FEV1 (in ml) in participants with AERD
Timepoint [17] 0 0
Baseline to Weeks 24 and 52
Secondary outcome [18] 0 0
Proportion of NPS responders (defined as participants with improvement by at least 1 point in NPS)
Timepoint [18] 0 0
Weeks 24 and 52
Secondary outcome [19] 0 0
Proportion of NPS responders (defined as participants with improvement by at least 2 points in NPS)
Timepoint [19] 0 0
Weeks 24 and 52
Secondary outcome [20] 0 0
Incidence of treatment-emergent adverse Events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events of special interest (TEAESIs) and TEAEs leading to treatment discontinuation
Timepoint [20] 0 0
Baseline to End of Study (EOS) (Week 72)
Secondary outcome [21] 0 0
Itepekimab concentration in serum
Timepoint [21] 0 0
Baseline to EOS (Week 72)
Secondary outcome [22] 0 0
Incidence of treatment-emergent anti-itepekimab antibody (ADA) responses
Timepoint [22] 0 0
Baseline to EOS (Week 72)

Eligibility
Key inclusion criteria
* Participants must be 18 years of age or older.
* Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening
* Participants must have at least one of the following features:

* Prior sinonasal surgery for nasal polyps (NP).
* Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 2 years before screening (Visit 1).
* 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.
* An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity) at screening and randomization.
* Ongoing symptoms (for at least 12 weeks before Visit 1) of:

* Nasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2), AND
* At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).
* 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:

* Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and aspirin-exacerbated respiratory disease (AERD) which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.
* Participants who are currently smoking tobacco and/or vaping, or participants in whom smoking/vaping cessation has occurred <6 months prior to Screening (Visit 1). Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco.
* Participants meet any contraindications for mometasone furoate nasal spray (MFNS) such as hypersensitivity to MFNS or any of its components; or participants with uncontrolled opportunistic infections.
* Participants with a history of a severe systemic hypersensitivity reaction to a mAb.
* 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 etc).
* Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.
* History of concomitant lung disease (other than asthma, eg, COPD, interstitial lung disease) which in the opinion of the Investigator could interfere with performance and interpretation of spirometry.
* Participants treated with intranasal corticosteroid(s) (INCS) (MFNS is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM during the screening period. In Japan and China INCS other than MFNS are permitted.
* Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1.
* Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
* Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/12/2027
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Spearwood
Recruitment postcode(s) [1] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Lancashire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06834360