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

Launched by SANOFI · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called itepekimab to see how well it works for people with chronic rhinosinusitis with nasal polyps, a condition that causes long-term nasal congestion and growths in the nasal passages. The trial will compare two different doses of itepekimab to a placebo (a treatment with no active ingredients) in adults aged 18 and older who have not had good control of their symptoms with standard treatments. Participants will be monitored over a period of up to 76 weeks, which includes a 52-week treatment phase and a follow-up period to ensure their safety.

To be eligible for the trial, participants must have a history of chronic rhinosinusitis with nasal polyps for at least one year, have certain symptoms like nasal blockage or loss of smell, and must have had prior treatments that did not fully work. The trial is open to both men and women, but there are specific health conditions that might prevent someone from participating, such as severe allergic reactions or recent surgeries. Participants can expect to visit the study site several times and have phone check-ins throughout the study to monitor their progress and any side effects from the treatment.

Gender

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Eligibility criteria

• 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).
• 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.