BridgeMD
A Proof of Concept study to assess the efficacy, safety and tolerability of itepekimab (antiIL33 mAb) in participants with chronic rhinosinusitis without nasal polyps
EU CTIS ID: 2024-515576-12-00
What this study is testing
To evaluate the efficacy of itepekimab compared with placebo on sinus opacification.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (SNOT22) score of ≥20 at Visit 1 and Visit 2.
You likely can't join if
- 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).
See the full eligibility criteria
Who can join
- 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 (SNOT22) 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).
What rules you out
- 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 study team makes the final eligibility decision.
Where it's taking place
- Canada
- Chile
- United States
- Korea, Republic of
- China
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Chile; United States; Korea, Republic of; China; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.