Chronic Rhinosinusitis Without Nasal Polyps
Study Overview
A Randomized, Double-blind, Placebo-controlled, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab in Participants With Inadequately Controlled Chronic Rhinosinusitis Without Nasal Polyps
ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 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 in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older.
You might be eligible to participate if the below criteria are met.
Inclusion Criteria:
Participant must be 18 years of age or older.
Participants must have at least one of the following features:
Prior sinonasal surgery (as protocol defined) for chronic rhinosinusitis (CRS).
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.
Participants who have received a stable dose of mometasone furoate nasal spray (MFNS) for at least 3 weeks before Visit 2.
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
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil).
Radiological suspicion or confirmed invasive or expansive fungal rhinosinusitis.
Sinus surgery within 6 months before Screening (Visit 1)
Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
Participants treated with other intranasal corticosteroid(s) (INCS) (only study provided AxMP [MFNS] is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as Xhance™ during the screening period.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.