BridgeMD
An extension study to investigate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps
EU CTIS ID: 2025-522983-33-00
What this study is testing
Evaluate the long-term safety and tolerability of itepekimab in participants with inadequately controlled CRSwNP who completed treatment in previous itepekimab CRSwNP clinical studies (EFC18418, EFC18419)
- Therapeutic confirmatory (Phase III)
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
- Participants with CRSwNP who completed the 52-weeks intervention period in a previous itepekimab CRSwNP Phase 3 clinical study (ie, EFC18418 or EFC18419) and for which an EOT visit occurred no later than 5 days before the enrollment visit of this study.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a women of childbearing potential (WOCBP), OR - Is a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.
You likely can't join if
- Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin.
- Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status.
- Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study.
- Any other situation that led to a permanent premature IMP discontinuation in parent trials.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- United States
- Israel
- Turkey
- Australia
- China
- Argentina
- Korea, Republic of
- Chile
- United Kingdom
- Canada
- Japan
- Brazil
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; United States; Israel; Turkey; Australia; China and 7 more location(s). 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.