depemokimab in participants with hypereosinophilic syndrome, efficacy, and safety trial

Conditions: Hypereosinophilic Syndrome

Summary: 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). eligible participants must have uncontrolled hes with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μl) during screening. historical hes flares are defined as documented hes-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their soc hes therapy.


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.

Keywords: depemokimab hypereosinophilic syndrome destiny monoclonal antibody anti-interleukin -5