Living with CRSwNP
Chronic rhinosinusitis with nasal polyps (CRSwNP) is an inflammatory disease in which soft, non-cancerous growths develop in the sinuses and nasal passages, causing symptoms like a persistent runny or stuffy nose, loss of smell or taste, and facial pain or pressure.
Current treatments for CRSwNP can help relieve symptoms, but many people with CRSwNP will eventually need surgery to remove the polyps. Unfortunately, polyps may return after surgery. Additional treatment options are needed to help people with CRSwNP manage their symptoms and reduce the need for surgery.
About the ANCHOR Studies
ANCHOR 1 and ANCHOR 2* are clinical trials, or research studies, of an investigational treatment for CRSwNP called depemokimab. These studies are evaluating if depemokimab is safe, and if it improves symptoms when added to standard of care treatments (currently approved medications) for CRSwNP.
Depemokimab is being developed as a potential long-acting treatment that may help reduce inflammation and improve symptoms of CRSwNP. It is given as an injection under the skin every six months. Depemokimab is considered investigational because it has not yet been approved for use outside of clinical trials.
*ANCHOR 1 & ANCHOR 2 are identical studies. If you are eligible and choose to participate, you will be enrolled in only one of the studies.
Who Can Participate?
This study may be an option for people who
- Are at least 18 years old
- Have severe nasal polyp symptoms (nasal congestion/blockage/obstruction with loss of smell or runny nose)
- Have nasal congestion/blockage/obstruction plus facial pain/pressure and/or reduction or loss of smell for at least 12 weeks
There are other requirements to participate in the ANCHOR studies. If you are pre-qualified, a study team member will be in touch to review additional eligibility criteria and help determine if this study is right for you.
What To Expect
If you are eligible and choose to take part in the ANCHOR studies, a computer will assign you by chance (like flipping a coin) to one of two treatment groups:
- Depemokimab (study drug given as an injection under the skin) + standard of care (normal treatment you would receive if you were not taking part in the study), OR
- Placebo (injection that looks like the study drug but does not contain any active medicine) + standard of care
After about a one-month screening period, you will receive an injection of depemokimab or placebo on Day 1 of the treatment period and a second injection approximately six months later. You will not know which one you receive. Your study doctor will also provide or prescribe standard of care treatment as needed.
You will be enrolled in the study for about 13 months. During this time, you will need to attend at least 17 study visits so the study doctor can assess your overall health and CRSwNP. These visits will occur two to four weeks apart. Most visits will be in-person at the study site, however some may be conducted over the phone or by video call, where allowed.
There is no cost to participate in the ANCHOR studies. Study related supplies, medications and examinations will be provided at no cost, including your standard of care for CRSwNP (such as your nasal spray). Compensation per visit and additional travel support will also be available. You will still need to pay for your regular healthcare.
Why Participate?
Before a potential treatment can be approved and made available to the general public, it must first be tested in a series of clinical trials. Clinical trials are an essential step in the process of developing new medications, and they are not possible without the participation of volunteers.
By choosing to volunteer in the ANCHOR studies, you will help us learn if the study drug depemokimab is safe, if it improves symptoms of CRSwNP when added to standard of care treatments, and if it can reduce the need for nasal surgery. The results of the studies may help other people living with CRSwNP in the future.
Frequently Asked Questions
What are the potential benefits of participating in the ANCHOR studies?
Your health and CRSwNP will be closely monitored throughout your time in the study, and you will receive all study-related procedures at no cost to you. Additionally, you have a chance of receiving an investigational drug that may improve your CRSwNP symptoms. It is possible that you may not experience any benefit from participating in these studies.
What are the potential risks of participating in the ANCHOR studies?
All research studies and medical treatments come with some risks. The study team will discuss all possible risks with you before you decide to participate.
Are clinical trials safe?
Clinical trials must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.; Before you can join any clinical trial, you need to read and sign an Informed Consent form. This form includes a full explanation of the study, including its potential risks, so you can make an informed decision about whether or not you want to join the study.; In addition to having a copy of the Informed Consent form for you to read, a study team member will discuss it with you and answer any questions you have. You should feel free to discuss the study with family, friends, and/or your doctor before you make your decision.
What if these studies are not right for me?
Participating in one of the ANCHOR studies is completely optional and up to you. You can choose to leave the study at any time, for any reason. Choosing not to participate will not affect your future medical care in any way.
Does it cost anything to participate?
As an eligible participant, you will receive the study drug or placebo, standard of care treatment, and related tests at no cost to you. Additionally, compensation and additional travel support is available. Please ask the study team for more information.