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New injection could shrink nasal polyps without surgery
NCT ID NCT07484230
First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times
Summary
This Phase 3 trial tests itepekimab, an injected antibody, in 20 Japanese adults with chronic sinusitis and nasal polyps that are not well-controlled despite surgery or steroids. The study measures changes in polyp size and nasal congestion over 52 weeks. It aims to see if the drug is safe and effective as a standalone treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- itepekimab (a monoclonal antibody injection)
- What this could lead to
- If it works, it could offer a new treatment option for people with nasal polyps that are not controlled by current therapies.
- What could go wrong
- This is a small, early-stage Phase 3 trial with only 20 participants, so results may not apply to everyone. The drug may not work better than placebo or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Expected to start
-
May 2026
An estimate. Start dates often move.
- Expected to finish
-
Oct 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must be 18 years of age or older. * Participants with a history of CRSwNP for at least 1 year. * Participants must have at least one of the following features: * Prior sinonasal surgery for NP. * Worsening symptoms of CRS requiring treatment with SCS within the prior 1 year. * An endoscopic bilateral NPS of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity). * Ongoing symptoms (for at least 12 weeks before Visit 1) of: * Nasal congestion/blockade/obstruction with moderate or severe symptom (score of 2 or 3), AND * At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior). * Not currently on and have not been receiving INCS for at least one month. * 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 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. Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco. * Participants with a history of a severe systemic hypersensitivity reaction to a mAb. * Participants with conditions/concomitant diseases making them non-evaluable 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. * Participants treated with intranasal corticosteroid(s) (INCS), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM one month prior during the screening period. * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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