What side effects are associated with this type of intervention?

Common treatments for nasal polyps, particularly monoclonal antibodies targeting IL-5 like depemokimab, often result in side effects such as injection site reactions, headache, and back pain. Less frequently, patients may experience hypersensitivity reactions and an increased risk of infections. Immune-related adverse events, such as eosinophilia, can also occur due to the immune system modulation.

What prior FDA approvals exist?

The FDA has approved several treatments for nasal polyps, including monoclonal antibodies that target inflammatory pathways. Dupilumab, a monoclonal antibody that targets IL-4 and IL-13, has been approved for the treatment of chronic rhinosinusitis with nasal polyps. It has shown efficacy in reducing nasal polyp size and improving symptoms such as nasal congestion. Similar to Depemokimab, which targets IL-5 to reduce inflammation and nasal polyp formation, these treatments aim to modulate the immune response to alleviate symptoms and improve quality of life for patients with nasal polyps.

What other types of research exist?

Promising alternatives to Depemokimab for nasal polyps in 2024 include anti-IL-23 agents such as ustekinumab, mirikizumab, risankizumab, brazikumab, and guselkumab. Additionally, dupilumab, which targets IL-4 and IL-13, is another potential option.

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Monoclonal Antibodies

Depemokimab for Nasal Polyps (ANCHOR-2 Trial)

Phase 3

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Participants with 18 years of age and older inclusive, at the time of signing the informed consent.

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

Must not have

Cystic fibrosis.

Antrochoanal polyps.

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 previous treatments like surgery or steroids, but still have severe symptoms. They must be using nasal corticosteroids for at least 8 weeks before the trial. Excluded are those with conditions like cystic fibrosis, vasculitis, recent radiation exposure, certain past drug studies, pregnancy, uncontrolled diseases, recent sinus infections or surgeries.

What is being tested?

The trial is testing Depemokimab (GSK3511294), a new medication against a placebo to see if it's effective and safe in treating chronic rhinosinusitis with nasal polyps. Participants will randomly receive either the medication or a placebo for comparison.

What are the potential side effects?

Possible side effects of Depemokimab may include allergic reactions to its components or general side effects common to monoclonal antibodies which can range from mild injection site reactions to more serious immune-related issues.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been using nasal steroid sprays or washes daily for at least 8 weeks.

Exclusion Criteria

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

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I have cystic fibrosis.

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I have antrochoanal polyps.

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I have a tumor in my nasal cavity.

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I have a fungal infection in my sinuses.

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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 not had nose surgery that changed the structure of my nose's side walls.

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I have ongoing nasal congestion caused by overusing nasal sprays.

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I was hospitalized for asthma within the last month.

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I haven't had any nose or sinus surgery in the last 6 months, except for a nasal biopsy.

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

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I am not allergic to any components of depemokimab.

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

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 (ACQ-5) score (scores on a scale)

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

Nose

+4 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 / 15Eligibility 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

Common treatments for nasal polyps, such as monoclonal antibodies like Depemokimab, work by targeting specific inflammatory pathways. Depemokimab, for instance, targets Interleukin-5 (IL-5), a cytokine involved in the activation and survival of eosinophils, which are white blood cells that contribute to inflammation and polyp formation. By inhibiting IL-5, these treatments reduce eosinophil activity, thereby decreasing inflammation and the size of nasal polyps. This is crucial for patients as it can lead to improved nasal airflow, reduced congestion, and overall better quality of life.

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].