The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with secondary hemophagocytic lymphohistiocytosis.
Description
This study is an open-label, single arm, multicenter interventional study, comprised of 4 cohorts; a dose escalating cohort (cohort 1) followed by 3 fixed dose cohorts (Cohorts 2-4). Newly diagnosed and previously treated participants with secondary hemophagocytic lymphohistiocytosis will be enrolled and treated over 12-weeks. Secondary hemophagocytic lymphohistiocytosis is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (m-HLH), infection, or autoimmune disease).
Eligibility Criteria
Ages Eligible for Study: 6 years and older (child, adult, older adult)
Sexes Eligible for Study: All
Treatment naïve or relapsed refractory HLH. Participant is hospitalized with HLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria
Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov