ITEPEKIMAB for Chronic rhinosinusitis with nasal polyps

Inclusion criteria

• {"criterion_text":"- Participants must be 18 years of age or older.\n- Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening\n- Participants must have at least one of the following features: o\tPrior sinonasal surgery for nasal polyps (NP). o\tWorsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 year before screening (Visit 1).\n- 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.\n- Ongoing symptoms (for at least 12 weeks before Visit 1) of: o\tNasal 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).\n- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: o\tIs not a women of childbearing potential (WOCBP), OR o\tIs 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)."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1.\n- Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).\n- 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.\n- 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.\n- 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.\n- Participants with a history of a severe systemic hypersensitivity reaction to a mAb.\n- Participants with conditions/concomitant diseases making them non­evaluable at Visit 1 or for the primary efficacy endpoint.\n- Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc).\n- Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.\n- 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.\n- 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."}

Primary endpoints

• {"endpoint_text":"- Change from baseline in the endoscopic NPS","definition_or_measurement_approach":"Endoscopic Nasal Polyp Score (NPS) assessed by endoscopy; change from baseline in NPS."}
• {"endpoint_text":"- Change from baseline in the NCS","definition_or_measurement_approach":"NCS = Nasal Congestion Score; change from baseline in the nasal congestion score (patient symptom scoring)."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in endoscopic NPS","definition_or_measurement_approach":"Endoscopic NPS assessed by endoscopy; change from baseline."}
• {"endpoint_text":"- Change from baseline in NCS","definition_or_measurement_approach":"Change from baseline in Nasal Congestion Score."}
• {"endpoint_text":"- Change from baseline in opacification of sinuses assessed by Computed Tomography (CT) scan using the LMK score","definition_or_measurement_approach":"Sinus opacification assessed by CT scan using the Lund-Mackay (LMK) score; change from baseline."}
• {"endpoint_text":"- Change from baseline in the TSS (nasal congestion/obstruction, anterior/posterior rhinorrhea, and loss of sense of smell)","definition_or_measurement_approach":"Total Symptom Score (TSS) composed of nasal congestion/obstruction, rhinorrhea, and loss of smell; change from baseline."}
• {"endpoint_text":"- Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary, and UPSIT score","definition_or_measurement_approach":"Patient-reported daily CRSwNP sinonasal symptom eDiary and University of Pennsylvania Smell Identification Test (UPSIT); change from baseline in loss of smell severity and UPSIT."}
• {"endpoint_text":"- Change from baseline in SNOT­22 total score","definition_or_measurement_approach":"Change from baseline in SNOT-22 total score (Sino-Nasal Outcome Test 22)."}
• {"endpoint_text":"- Change from baseline in PROMIS SD­SF­8b scores","definition_or_measurement_approach":"Change from baseline in PROMIS Sleep Disturbance Short Form 8b scores."}
• {"endpoint_text":"- Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for CRS","definition_or_measurement_approach":"Proportion of participants meeting the outcome (requiring SCS or sinus surgery) during study period."}
• {"endpoint_text":"- Annualized rate of SCS course or surgery for CRS","definition_or_measurement_approach":"Annualized event rate of systemic corticosteroid courses or CRS-related surgeries."}
• {"endpoint_text":"- Time to first either SCS or surgery for CRS","definition_or_measurement_approach":"Time-to-event analysis measuring time from randomization to first systemic corticosteroid course or CRS surgery."}
• {"endpoint_text":"- Change from baseline in pre BD FEV1 (in mL) in participants with co-morbid asthma","definition_or_measurement_approach":"Change from baseline in pre-bronchodilator FEV1 (mL) in the subgroup with comorbid asthma."}
• {"endpoint_text":"- Change from baseline in ACQ 5 score in participants with co-morbid asthma","definition_or_measurement_approach":"Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score in participants with comorbid asthma."}
• {"endpoint_text":"- Change from the baseline in NPS and NCS in the subgroup of patients with aspirin-exacerbated respiratory disease (AERD)","definition_or_measurement_approach":"Change from baseline in NPS and NCS in the AERD subgroup."}
• {"endpoint_text":"- Proportion of participants with AERD requiring SCS or surgery for CRS","definition_or_measurement_approach":"Proportion of AERD participants requiring systemic corticosteroids or CRS surgery."}
• {"endpoint_text":"- Annualized rate of SCS course or surgery for CRS in participants with AERD","definition_or_measurement_approach":"Annualized rate of SCS courses or CRS surgeries in the AERD subgroup."}
• {"endpoint_text":"- Time to first either SCS or surgery for CRS in participants with AERD","definition_or_measurement_approach":"Time-to-event to first SCS or surgery in participants with AERD."}
• {"endpoint_text":"- Change from baseline in pre BD FEV1 (in ml) in participants with AERD","definition_or_measurement_approach":"Change from baseline in pre-BD FEV1 (mL) in AERD subgroup."}
• {"endpoint_text":"- Proportion of NPS responders (defined as participants with improvement by at least 1 point in NPS)","definition_or_measurement_approach":"Proportion of participants with ≥1-point improvement in NPS."}
• {"endpoint_text":"- Proportion of NPS responders (defined as participants with improvement by at least 2 points in NPS)","definition_or_measurement_approach":"Proportion of participants with ≥2-point improvement in NPS."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Safety endpoints measured as incidence counts/rates of TEAEs, TESAEs, TEAESIs and TEAEs leading to discontinuation."}
• {"endpoint_text":"- Itepekimab concentration in serum","definition_or_measurement_approach":"Pharmacokinetic measurement of itepekimab serum concentration."}
• {"endpoint_text":"- Incidence of treatment emergent anti itepekimab antibody (ADA) responses","definition_or_measurement_approach":"Incidence of anti-drug antibody (ADA) responses emerging during treatment."}

Methods

• Doctor-to-doctor letters (HCP referral communications) – country-specific versions provided (e.g., EN, FR, NL, CS, DA, HU, IT, ES, RO, DE).
• Patient-facing printed materials (flyers, posters, brochures) – country/language-specific versions.
• Digital recruitment (social media posts, landing pages, digital marketing content) – patient-targeted digital materials in multiple languages.
• Patient invitation / PI-to-patient letters – language-specific patient invitation letters.
• Self-assessment tools and patient eDiary (CRSwNP sinonasal symptom eDiary) – online/digital self-assessment to identify eligible patients.
• Placebo informational videoscripts and placebo factsheets – patient-facing multimedia recruitment material.
• Privacy-policy and secondary assessment communications – materials describing data/privacy and next-steps for interested participants.

Belgium

Earliest CTIS Part Ii Submission Date

05-03-2025

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

175

Number Of Sites

4

Number Of Participants

11

Czechia

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

03-07-2025

Processing Time Days

98

Number Of Sites

5

Number Of Participants

11

Denmark

Earliest CTIS Part Ii Submission Date

05-03-2025

Latest Decision Or Authorization Date

04-08-2025

Processing Time Days

152

Number Of Sites

3

Number Of Participants

7

Hungary

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

15-07-2025

Processing Time Days

110

Number Of Sites

2

Number Of Participants

11

Netherlands

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

30-07-2025

Processing Time Days

125

Number Of Sites

2

Number Of Participants

5

Poland

Earliest CTIS Part Ii Submission Date

04-03-2025

Latest Decision Or Authorization Date

03-07-2025

Processing Time Days

121

Number Of Sites

4

Number Of Participants

13

Romania

Earliest CTIS Part Ii Submission Date

10-12-2024

Latest Decision Or Authorization Date

12-09-2025

Processing Time Days

276

Number Of Sites

3

Number Of Participants

15

Spain

Earliest CTIS Part Ii Submission Date

07-03-2025

Latest Decision Or Authorization Date

05-11-2025

Processing Time Days

243

Number Of Sites

6

Number Of Participants

20

France

Earliest CTIS Part Ii Submission Date

20-02-2025

Latest Decision Or Authorization Date

14-11-2025

Processing Time Days

267

Number Of Sites

8

Number Of Participants

11

Germany

Earliest CTIS Part Ii Submission Date

21-01-2025

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

387

Number Of Sites

11

Number Of Participants

20

Italy

Earliest CTIS Part Ii Submission Date

10-12-2024

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

514

Number Of Sites

3

Number Of Participants

11

Primary sponsor

Full Name

Sanofi-Aventis Recherche & Developpement

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

ESMS Global Limited

Responsibilities

Centralized 24-Hour Emergency System: eSMS

Name

Suvoda LLC

Responsibilities

Interactive response technologies (IRT)

Name

Bioclinica Inc.

Responsibilities

Central imaging

Name

Labcorp Central Laboratory Services LP

Responsibilities

code: 4 (central lab role indicated by organisation and context)

Third parties

• {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Marken","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Interactive response technologies (IRT)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"France","full_name":"Inato","duties_or_roles":"code: 2","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medpoint Communications Inc.","duties_or_roles":"code: 8","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Hungary","full_name":"European Pharma Hub Kft.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Romania","full_name":"Alliance Healthcare Romania S.R.L.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"code: 14","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code: 7","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"code: 7","organisation_type":"Pharmaceutical company"}