What side effects are associated with this type of intervention?

Common treatments for nasal polyps, particularly those involving monoclonal antibodies targeting IL-5 such as Depemokimab, often include side effects like headache, injection site reactions, and nasopharyngitis. Other potential side effects can include upper respiratory tract infections, gastrointestinal symptoms, and, less commonly, hypersensitivity reactions. These treatments aim to reduce inflammation and polyp size but require monitoring for these adverse effects.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of nasal polyps, particularly those targeting inflammatory pathways. Dupilumab, an IL-4 and IL-13 receptor antagonist, has shown efficacy in reducing nasal polyp size and symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Omalizumab, an anti-IgE antibody, has also been approved for this condition. These treatments, like depemokimab, aim to reduce inflammation and polyp formation by targeting specific components of the immune response.

What other types of research exist?

Promising alternatives to Depemokimab for treating nasal polyps include Dupilumab, which targets IL-4 and IL-13, and Omalizumab, which targets IgE. Both have shown efficacy in reducing nasal polyp size and associated symptoms.

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Monoclonal Antibodies

Depemokimab for Nasal Polyps (ANCHOR-1 Trial)

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants (except for those in Japan) must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least the 8 weeks immediately prior to screening

Participants presenting with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhea (runny nose) based on clinical assessment by the investigator

Must not have

A known immunodeficiency (e.g. human immunodeficiency virus [HIV]), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma

Women who are pregnant or lactating or are planning on becoming pregnant during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and from week 49 to week 52

Awards & highlights

Pivotal Trial

Summary

This trial will test a new medication called depemokimab to see if it can help people with long-term nasal inflammation and growths. The goal is to reduce swelling and shrink the growths in their noses.

Who is the study for?

Adults with chronic rhinosinusitis and nasal polyps who've had symptoms for at least 12 weeks, including nasal blockage or discharge, facial pain, or loss of smell. They must have been on daily nasal corticosteroid treatment for 8 weeks prior to screening and may have had previous surgery or steroid treatments for polyps. Exclusions include those unfit for the study due to other health issues, recent cancer survivors, severe septal deviation, acute sinusitis or infections before screening, pregnant women, certain systemic abnormalities uncontrolled by treatment.

What is being tested?

The trial is testing Depemokimab (GSK3511294), a new medication against a placebo in people with chronic rhinosinusitis with nasal polyps (CRSwNP). The goal is to see if Depemokimab can effectively reduce symptoms compared to not receiving the active drug.

What are the potential side effects?

Possible side effects of Depemokimab are not detailed but could be similar to other monoclonal antibodies which often include allergic reactions at the injection site, headache, fatigue and potential immune system impacts leading to increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been using nasal steroid sprays or washes daily for the last 8 weeks.

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I have severe nasal problems, including congestion, loss of smell, or a runny nose.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an immune system condition not caused by my asthma medication.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have a fungal infection in my sinuses.

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I have not been in a study with mepolizumab, reslizumab, or benralizumab in the last year.

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I have antrochoanal polyps.

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I was hospitalized for asthma within the last month.

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I've had nose surgery that changed the structure, affecting nasal polyp score assessments.

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I have a severe blockage in one nostril due to a deviated septum, making it hard to check for nasal polyps.

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I have a tumor in my nasal cavity.

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I have been exposed to more than 10 mSv of radiation due to work or research in the last 3 years.

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My cancer has been in remission for less than a year.

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I am currently experiencing a persistent stuffy nose due to long-term nasal spray use.

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I have a serious health condition that isn't managed well with treatment.

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I have cystic fibrosis.

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I am not allergic to any components of depemokimab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and from week 49 to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and from week 49 to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and from week 49 to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in mean nasal obstruction score using verbal response scale (VRS) from Weeks 49 to 52 (Scores on a scale)

Change from Baseline in total endoscopic Nasal polyps (NP) score at Week 52 (Scores on a scale)

Secondary study objectives

Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score (Scores on a scale)

Change from Baseline in Lund Mackay (LMK) computed tomography (CT) score (Scores on a scale)

Change from Baseline in Sino-Nasal Outcome Test (SNOT)-22 total score (Scores on a scale)

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving depemokimab (GSK3511294)Experimental Treatment1 Intervention

Group II: Participants receiving placeboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Depemokimab (GSK3511294)

2022

Completed Phase 3

~280

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for nasal polyps include monoclonal antibodies, corticosteroids, and surgery. Monoclonal antibodies like Depemokimab target interleukin-5 (IL-5), a key cytokine involved in the inflammatory process that leads to nasal polyp formation. By inhibiting IL-5, these treatments reduce eosinophilic inflammation, thereby decreasing the size and number of polyps. This is crucial for patients as it can significantly improve nasal airflow, reduce congestion, and enhance overall quality of life. Corticosteroids, either systemic or topical, also reduce inflammation but have broader effects and potential side effects. Surgery is often reserved for severe cases but does not address the underlying inflammation, leading to potential recurrence.

Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps.[Allergic rhinitis: still insufficiently responsive to therapies].