What is the mechanism of action of this treatment?

The most common treatments for Hypereosinophilic Syndrome (HES) work by reducing eosinophil levels in the blood. Depemokimab, for example, is a monoclonal antibody that targets and neutralizes interleukin-5 (IL-5), a key cytokine involved in the growth, activation, and survival of eosinophils. By inhibiting IL-5, depemokimab effectively reduces the number of eosinophils, thereby alleviating the symptoms and preventing the complications associated with HES. This mechanism is crucial for HES patients as it directly addresses the root cause of their condition, leading to better disease management and improved quality of life.

What side effects are associated with this type of intervention?

Common treatments for Hypereosinophilic Syndrome (HES) that reduce eosinophil levels include corticosteroids, tyrosine kinase inhibitors, and monoclonal antibodies. Corticosteroids can cause weight gain, hypertension, diabetes, osteoporosis, and increased infection risk. Tyrosine kinase inhibitors may lead to fluid retention, muscle cramps, and gastrointestinal issues. Monoclonal antibodies like mepolizumab can cause injection site reactions, headache, and back pain. Depemokimab, being a monoclonal antibody, may have similar side effects to mepolizumab.

What prior FDA approvals exist?

The FDA has approved several treatments for Hypereosinophilic Syndrome (HES) that target eosinophil levels. Mepolizumab, an anti-IL-5 monoclonal antibody, is one such drug that reduces eosinophil levels and has been approved for HES. Another similar treatment is benralizumab, which also targets IL-5 and reduces eosinophil counts. These treatments are similar to depemokimab, which is currently being studied for its efficacy in reducing eosinophil levels in HES patients.

What other types of research exist?

Promising novel alternatives to Depemokimab for Hypereosinophilic Syndrome patients include: 1) Benralizumab, an anti-IL-5 receptor monoclonal antibody that depletes eosinophils and has shown efficacy in clinical trials for eosinophilic conditions. 2) Mepolizumab, another anti-IL-5 monoclonal antibody, which has been effective in reducing eosinophil levels and managing HES symptoms. 3) Reslizumab, an anti-IL-5 monoclonal antibody, which has demonstrated benefits in reducing eosinophil counts and improving clinical outcomes in eosinophilic disorders.

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Depemokimab for Hypereosinophilic Syndrome (DESTINY 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

A history of 2 or more HES flares within the past 12 months prior to Visit 1

Participants who are greater than or equal (>=) 40 kilogram (kg) at Screening Visit 1

Must not have

Cirrhosis or current unstable liver or biliary disease per investigator assessment

Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplastic syndrome, chronic eosinophilic leukaemia-not otherwise specified

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 52 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called depemokimab for adults with Hypereosinophilic Syndrome (HES) who are not responding well to their current treatments. The medication aims to lower the number of certain white blood cells that cause symptoms to worsen. Participants will either receive depemokimab or continue their usual treatment.

Who is the study for?

Adults with Hypereosinophilic Syndrome (HES) who are not pregnant or breastfeeding, weigh at least 40 kg, have had a confirmed HES diagnosis and experienced two or more flares in the past year can join. They must be on stable HES therapy for four weeks before the trial and cannot have certain cancers, heart issues, severe allergies to monoclonal antibodies, or other specific health conditions.

What is being tested?

The study is testing Depemokimab against a placebo in people with uncontrolled HES over one year. Participants will continue their standard care while being randomly assigned to either receive Depemokimab or a placebo in a 2:1 ratio.

What are the potential side effects?

Potential side effects of Depemokimab may include reactions similar to those seen with other monoclonal antibody treatments such as infusion-related reactions, immune system changes leading to inflammation of organs, fatigue, allergic responses and possibly an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have had 2 or more episodes of severe allergic reactions in the last year.

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I weigh at least 40 kg.

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I have been diagnosed with HES before my second visit.

Exclusion Criteria

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

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My liver is not stable or I have cirrhosis, as assessed by a doctor.

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I have a blood cancer with high eosinophil levels, but it's not primarily due to HES.

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I have been diagnosed with EGPA.

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I am allergic to certain medication ingredients or biologic treatments.

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My tests show I have the FIP1L1-PDGFRα gene fusion.

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I have tried and not responded to anti-IL-5/5R therapy before.

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My heart condition is severe and not controlled by standard treatments.

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I have been diagnosed with vasculitis.

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I haven't needed treatment for an infection or had parasites in the last 6 months.

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I have or had lymphoma.

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I have high eosinophil levels without symptoms or organ issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency of HES flares

Secondary study objectives

Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours)

Time to first HES flare

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: DepemokimabExperimental Treatment1 Intervention

All participants in this arm will receive depemokimab.

Group II: PlaceboPlacebo Group1 Intervention

All participants in this arm will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Depemokimab

2022

Completed Phase 1

~140

0 / 14Eligibility 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 Hypereosinophilic Syndrome (HES) work by reducing eosinophil levels in the blood. Depemokimab, for example, is a monoclonal antibody that targets and neutralizes interleukin-5 (IL-5), a key cytokine involved in the growth, activation, and survival of eosinophils. By inhibiting IL-5, depemokimab effectively reduces the number of eosinophils, thereby alleviating the symptoms and preventing the complications associated with HES. This mechanism is crucial for HES patients as it directly addresses the root cause of their condition, leading to better disease management and improved quality of life.