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Tests treatment safety and results for Hypereosinophilic Syndrome
Official title Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
ClinicalTrials.gov ID: NCT05334368
What this study is testing
What is Depemokimab?
Depemokimab is an investigational medicine, being studied as a potential treatment for hypereosinophilic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants who are greater than or equal (\>=) 40 kilogram (kg) at Screening Visit 1.
- Participants who have a documented diagnosis of HES prior to Visit 2.
- A history of 2 or more HES flares within the past 12 months prior to Visit 1.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) woman of...
- Capable of giving signed informed consent.
You likely can't join if
- Participants with HES disease manifestations which in the opinion of the investigator may put the participant at unacceptable risk from study...
- Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to...
- Participants with a known immunodeficiency (e.g., Human Immunodeficiency Virus [HIV]), other than that explained by the use of OCS or other therapy...
- Participants with a history of or current lymphoma.
- Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had...
- Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia...
See the full eligibility criteria
- Participants who are greater than or equal (\>=) 40 kilogram (kg) at Screening Visit 1.
- Participants who have a documented diagnosis of HES prior to Visit 2.
- A history of 2 or more HES flares within the past 12 months prior to Visit 1.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) woman of non-childbearing potential (WONCBP) Or b) woman of childbearing potential...
- Capable of giving signed informed consent.
- Participants with HES disease manifestations which in the opinion of the investigator may put the participant at unacceptable risk from study participation or confound interpretation of how well it works or safety data.
- Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to Visit 1.
- Participants with a known immunodeficiency (e.g., Human Immunodeficiency Virus [HIV]), other than that explained by the use of OCS or other therapy taken for HES.
- Participants with a history of or current lymphoma.
- Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was...
- 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...
- Cirrhosis or current unstable liver or biliary disease per investigator assessment.
- Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
- Participants with current diagnosis of vasculitis.
- Hypereosinophila with no clinical symptoms and/or proof of organ dysfunction.
- Clinical diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA).
- Participants with an allergy/ intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product.
- Participants who have a previous documented failure with anti-interleukin (IL)-5/5R therapy.
- Participants who have received monoclonal antibodies (mAb) within 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
- Participants who test positive for the FIP1L1-PDGFRα fusion gene.
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥450 milliseconds (msec) or QTcF ≥480 msec for participants with Bundle Branch Block at Screening Visit 1.
- Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator.
- Participants who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Southfield, Michigan, United States
- Rochester, Minnesota, United States
- Manhasset, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Buenos Aires, Argentina
- Florida, Argentina
- La Plata, Argentina
- Mar del Plata, Argentina
- Quilmes, Argentina
- Garran, Australian Capital Territory, Australia
- Brussels, Belgium
- Porto Alegre, Rio Grande do Sul, Brazil
- Blumenau, Brazil
+ 62 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Southfield, Michigan, United States; Rochester, Minnesota, United States; Manhasset, New York, United States and 76 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.