An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps
This study is an extension to previous research on a medicine called itepekimab. It's for adults who have a long-lasting condition called chronic rhinosinusitis with nasal polyps (CRSwNP), which leads to inflamed sinuses and growths inside the nose. The main goal is to understand the long-term safety and how well itepekimab works over time. Researchers also want to see how the medicine behaves in the body and if the immune system reacts to it. Only people who have already completed a 52-week part of one of two earlier studies (EFC18418 or EFC18419) are invited to join. The study will last up to 72 weeks, including treatment and follow-up, to gather important information about this potential new treatment.
At a glance
What is this study about?
This study is called an 'extension study' because it builds on previous research. It's designed for people who have a condition called chronic rhinosinusitis with nasal polyps (CRSwNP). This is a long-term problem where the lining of your sinuses and nose becomes inflamed, and soft, non-cancerous growths called nasal polyps can develop. This can lead to symptoms like a blocked nose, loss of smell, and facial pain.
The main purpose of this study is to learn more about the long-term safety of a medicine called itepekimab (pronounced eye-tep-e-kim-ab). The researchers want to understand any side effects that might happen over a longer period, and how well the treatment continues to work. They are also looking at how the body handles the medicine and if your immune system reacts to it.
Only people who have already participated in one of two specific earlier studies (EFC18418 or EFC18419) and completed a 52-week treatment period in those trials are eligible to join this extension study. This is important because the researchers are tracking how the medicine affects those individuals over an even longer period. This type of research helps doctors understand if a new medicine can be used safely and effectively for a long time.
Key takeaways
- This study is for adults with chronic rhinosinusitis with nasal polyps.
- It's an extension of a previous study looking at the long-term safety and effects of itepekimab.
- Participation lasts up to 72 weeks, including treatment and follow-up.
- You must have completed earlier itepekimab studies (EFC18418 or EFC18419) to be eligible.
- There are 8 clinic visits and 4 phone calls over the study period.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. A key requirement is that you must have already successfully completed the 52-week treatment part of one of two previous studies involving itepekimab (studies EFC18418 or EFC18419). You also need to have had your final visit for that previous study no more than 5 days before starting this new one.
For women, you can join if you are not pregnant or breastfeeding. If you are able to become pregnant, you'll need to use reliable contraception during the study and for about 20 weeks after your last dose of the study medicine. This is to ensure your safety and the safety of any potential pregnancy.
You cannot join if you developed cancer (except for certain skin cancers) during the earlier study, or if you had any serious infections that suggested your immune system was weakened. Also, if you had a severe allergic reaction to the study medicine in the previous trial that required treatment, or if you had to stop the earlier study medicine permanently for any other reason, you won't be able to participate in this extension study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Did you complete the 52-week treatment part of either study EFC18418 or EFC18419?
- If you are a woman, are you not pregnant or breastfeeding, and are you willing to use contraception if needed?
- Did you avoid any serious infections or new cancers (other than certain skin cancers) during your previous study?
- Did you avoid severe allergic reactions to the study medicine in your previous study?
What does participation involve?
If you decide to take part in this study, you will be involved for a total of up to 72 weeks (about a year and a half). The actual treatment with itepekimab will last for 52 weeks (one year). After your treatment period, there will be a follow-up period of 20 weeks to see how you are doing without the study medicine.
Throughout the study, you'll need to attend 8 visits to the study clinic. In addition to these visits, the study team will also contact you by phone 4 times to check in on your progress and well-being. During your visits, the research team will monitor your health, ask about any symptoms or side effects, and perform any necessary tests to understand how the medicine is working and to ensure your safety.
Potential risks and benefits
Locations (15)
- Velocity Clinical Research - San Diego- Site Number : 8402041Verified postcodeLa Mesa, United States
- Allergy, Asthma and Clinical Research- Site Number : 8402002Verified postcodeOklahoma City, United States
- Investigational Site Number : 0362001Verified postcodeSpearwood, Australia
- Investigational Site Number : 1241001Verified postcodeQuébec, Canada
- Investigational Site Number : 1521003Verified postcodeTalca, Chile
- Investigational Site Number : 1522003Verified postcodeSantiago, Chile
- Investigational Site Number : 1521002Verified postcodeSantiago, Chile
- Investigational Site Number : 1562001Verified postcodeBeijing, China
- Investigational Site Number : 1562004Verified postcodeChengdu, China
- Investigational Site Number : 1562008Verified postcodeJingzhou, China
- Investigational Site Number : 1562006Verified postcodeShenyang, China
- Investigational Site Number : 1562010Verified postcodeTaiyuan, China
Common questions
What is chronic rhinosinusitis with nasal polyps (CRSwNP)?
It's a long-lasting condition where the lining of your sinuses and nose gets inflamed, often with soft growths called nasal polyps, causing symptoms like a stuffy nose.
What is itepekimab?
Itepekimab is a medicine being tested to see if it can help adults with CRSwNP. This study is looking at its long-term safety and effectiveness.
Why is this an 'extension study'?
It's called an extension study because it continues to follow people who have already been part of an earlier study (EFC18418 or EFC18419) with the same medicine, to gather more long-term information.
How long will I be in this study?
If you join, the study will last for up to 72 weeks (about a year and a half). This includes 52 weeks of treatment and 20 weeks of follow-up.
Can I still participate if I got very sick in the last study?
No, if you had a severe allergic reaction to the study medicine, had cancer (other than specific skin cancers), or serious infections during the previous study, you would not be able to join this extension study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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