A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

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Description

If you choose to participate, you will have 17 visits for a little over 1 year. Most visits will be about 4 weeks apart; some will be 2 weeks apart. Visits are typically about 2 hours long, but the first visit, two injection visits, and the second to last visit will take about 6 hours. There are also some visits where we can do a telehealth visit with you, so you won't need to come to clinic. We will be asking you some questions, providing you a mobile device for you to complete questions once a day, conducing physical exams and vital signs, having doctors look inside your nose (nasal endoscopy), going for a CT Scan at the beginning and end of the study, looking at the electrical activity of your heart (Electrocardiogram (ECG)), asking you about your health and your medications, doing blood and urine tests, if you are able to become pregnant we will check to see if you are pregnant, and providing the study drug or a placebo. The placebo contains no active medicine. Like the study drug, it will be given as one injection under the skin every 6 months. Clinical trials often include a placebo so that effects seen in people who receive a study drug can be compared to effects seen in people who do not receive a study drug.

Details
Age

Adult

Eligibility

Some of the inclusion/exclusion criteria are below, there are other criteria. Inclusion: * 18 years and older * Severe nasal polyp symptoms for the past 12 weeks in addition to nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip) * Taking daily treatment with intranasal corticosteroids, such as a nasal spray known as Flonase, for the last 8 weeks? Exclusion: * Has cystic fibrosis, antrochoanal polyps, nasal cavity tumor, fungal rhinosinusitis, severe deviated septum, HIV, liver disease such as cirrhosis, or vasculitis * A pre-existing parasitic infection within 6 months

Type of Study

Treatment

Scope

National

Locations

Anschutz Health and Wellness
University of Colorado Hospital

Principal Investigator
Photograph of Ashoke Khanwalkar,  MD

Ashoke Khanwalkar, MD

Study ID

Protocol Number: 22-1480

More information available at ClinicalTrials.gov: NCT05274750

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