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Evaluating Itepekimab for Chronic Rhinosinusitis Without Nasal Polyps

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

Phase 2 Interventional Sanofi · NCT06691113

This study is testing a new medication called itepekimab to see if it helps adults with chronic rhinosinusitis without nasal polyps feel better compared to a placebo and a common nasal spray.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsitepekimab
Locations53 sites (Birmingham, Alabama and 52 other locations)
Trial IDNCT06691113 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, multinational, randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of itepekimab in participants aged 18 and older with chronic rhinosinusitis without nasal polyps. The study involves three treatment groups receiving either itepekimab, a placebo, or mometasone furoate nasal spray over a 24-week intervention period, followed by a 20-week safety follow-up. Participants will undergo a total of 15 visits, including both site and remote assessments, to monitor their symptoms and treatment responses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with ongoing symptoms of nasal congestion and a history of chronic rhinosinusitis without nasal polyps.

Not a fit: Patients who do not have chronic rhinosinusitis or those with nasal polyps may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of chronic rhinosinusitis without nasal polyps, offering relief to patients suffering from this condition.

How similar studies have performed: Previous studies have shown promise in targeting IL-33 for chronic rhinosinusitis, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant must be 18 years of age or older.
* Participants must have ongoing symptoms of nasal congestion/obstruction at least 12 consecutive weeks before Visit 1 and a Nasal Congestion Score (NCS) ≥2 at Visit 1 (day score) and Visit 2 (weekly average score).
* Participants must have sinus Total Symptom Score (sTSS) (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score).
* 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 must have bilateral inflammation of paranasal sinuses with bilateral ethmoid and maxillary opacification on screening CT scan. Participants must have ≥25% opacification of the ethmoid sinuses and ≥25% opacification of at least 1 maxillary sinus by central reading of CT scan.
* Participants must have a Sino-Nasal Outcome Test-22-Items (SNOT-22) score of ≥20 at Visit 1 and Visit 2.
* 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, 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 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).
* Radiological suspicion or confirmed invasive or expansive fungal rhinosinusitis.
* Have any clinically significant diseases or disorders (eg, cardiovascular, pulmonary, gastrointestinal, liver, kidney, neurological, musculoskeletal, endocrine, metabolic, psychiatric, physical impairment) that, in the opinion of the Investigator, may put the subject at risk by participating in the study, or interfere with the subject's intervention, assessment, or influence the results of the study, or have compliance issues with the study.
* 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.
* Participants with a history of severe systemic hypersensitivity reaction to mAb.
* Known allergy to itepekimab or to its excipients. Any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

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

Where this trial is running

Birmingham, Alabama and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Rhinosinusitis Without Nasal Polyps
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.