Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

Launched by GLAXOSMITHKLINE · Apr 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called depemokimab for adults with Hypereosinophilic Syndrome (HES), a condition where the body produces too many eosinophils, a type of white blood cell. The trial lasts for 52 weeks and compares depemokimab to a placebo (a substance with no active treatment) while participants continue their usual HES therapy. To be eligible, participants must be at least 40 kg, have a confirmed diagnosis of HES, and have experienced two or more flare-ups of their condition in the past year. They also need to have a certain level of eosinophils in their blood during screening.

Participants in this study will be randomly assigned to receive either the new treatment or the placebo, and they will closely monitor their health and symptoms throughout the trial. This study is currently recruiting and aims to find out if depemokimab is effective and safe for people struggling to manage their HES. It's important to note that certain health conditions and recent treatments may exclude some individuals from participating. If you or someone you know has HES and is interested in this study, it may be a good idea to talk to a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion 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 (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percentage (%).
• • Capable of giving signed informed consent.
• Exclusion Criteria:
• • 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 efficacy 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 resected for cure will not be excluded.
• • 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.
• • 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.