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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
Capable of giving signed informed consent
A history of 2 or more HES flares within the past 12 months prior to Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
DESTINY Trial Summary
This trialwill test a drug to control HES flare-ups in adults with uncontrolled HES who are already on standard therapy.
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.Check my eligibility
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.See study design
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.
DESTINY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to understand and sign the consent form.
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I have had 2 or more episodes of severe allergic reactions in the last year.
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I am not pregnant or breastfeeding and either cannot become pregnant or am using effective birth control.
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I weigh at least 40 kg.
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I have been diagnosed with HES before my second visit.
DESTINY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of HES flares
Secondary outcome measures
Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours)
Number of participants with at least one HES flare during the 52-week study intervention period
Time to first HES flare
DESTINY 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.
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,748 Previous Clinical Trials
8,067,392 Total Patients Enrolled
7 Trials studying Hypereosinophilic Syndrome
409 Patients Enrolled for Hypereosinophilic Syndrome
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,858 Total Patients Enrolled
6 Trials studying Hypereosinophilic Syndrome
399 Patients Enrolled for Hypereosinophilic Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and sign the consent form.My liver is not stable or I have cirrhosis, as assessed by a doctor.I have had 2 or more episodes of severe allergic reactions in the last year.You have been treated with oral corticosteroids (OCS) but did not show improvement in symptoms or blood test results according to the doctor's opinion.I have a blood cancer with high eosinophil levels, but it's not primarily due to HES.I have been diagnosed with EGPA.I am allergic to certain medication ingredients or biologic treatments.I haven't taken any monoclonal antibodies in the last 30 days or 5 half-lives.If you have a condition called HES (hypereosinophilic syndrome) that could make it too risky for you to take part in the study or could make it harder to understand the results.My tests show I have the FIP1L1-PDGFRα gene fusion.I have been cancer-free for less than 5 years, except for treated skin cancer.I am not pregnant or breastfeeding and either cannot become pregnant or am using effective birth control.I have an immune system problem not caused by my current medications.I have tried and not responded to anti-IL-5/5R therapy before.My heart condition is severe and not controlled by standard treatments.I have been diagnosed with vasculitis.I haven't needed treatment for an infection or had parasites in the last 6 months.I weigh at least 40 kg.I have or had lymphoma.I have high eosinophil levels without symptoms or organ issues.I have been diagnosed with HES before my second visit.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Depemokimab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When might we see Depemokimab available for general use?
"Depemokimab has received a score of 3 for safety from our team at Power. This is because Depemokimab is in Phase 3 trials, which means that there is some data to support both efficacy and safety."
Answered by AI
Are there opportunities for new participants in this experiment?
"The clinical trial is recruiting participants and was first posted on September 6, 2022. The most recent update was on October 31, 2022."
Answered by AI
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