Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Sanofi (Voir sur ClinicalTrials)
février 2025
décembre 2027
14 septembre 2025
EFC18419 is a multinational, randomized, double-blind, placebo-controlled,
parallel-group, Phase 3 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 as add-on therapy to intranasal corticosteroids (INCS) in male and
female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years
of age and older.
Study details include:
- The study duration per participant (4-week screening, 52-week treatment, 20-week
safety follow-up) will be up to 76 weeks. For participants transitioning to the
LTS18420 study, the study duration will be 56 weeks.
- The treatment duration will be up to 52 weeks.
- The number of visits will be 9 site visits and 20 phone/home visits.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | FAUCON Benoît | 18/09/2025 17:50:05 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Investigational Site Number : 2500004 - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500005 - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500010 - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500011 - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500014 - 95300 - Pontoise - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 1 year before screening
(Visit 1).
- 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).
- 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 1 year before screening
(Visit 1).
- 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).
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.