Testing Depemokimab against a placebo for hypereosinophilic syndrome

Exclusion

• −Participants with an allergy/ intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product.
• −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 HES disease manifestations which in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 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 treatmentStandard of careThe treatment normally given for a condition outside a study.Read more →.
• −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 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 VisitScreeningThe checks done before joining, to see whether a study fits.Read more → 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.