ELECTRA

• Research type

  Research Study

• Full title

  A Phase 1b, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of ELA026 in Adults and Adolescents with Secondary Hemophagocytic Lymphohistiocytosis (sHLH).

• IRAS ID

  302079

• Contact name

  Satyen Gohil

• Contact email

  uclh.randd@nhs.net

• Sponsor organisation

  Electra Therapeutics, Inc.

• Eudract number

  2021-001387-20

• Duration of Study in the UK

  1 years, 2 months, days

• Research summary

  The clinical trial (ELA026-CP002) is a phase IB, open label multicentre study to investigate the safety, efficacy pharmacokinetics and pharmacodynamics of the study drug (ELA026) with patients with sHLH.

  The study will be conducted in upto 24 participant diagnosed with sHLH ≥12 years in 4 cohorts.

  Participants receive IV doses of study drug ranging from 0.3 mg/kg/day to 3 mg/kg/day administered with dexamethasone. Cohorts 1 is anticipated to be 4 weeks of initial IV dose infusions and a subsequent IV or SC dose injection phase up to 12 weeks. Dose administration for subsequent Cohorts 2, 3 and 4 may be either by IV infusion or SC injection for up to 12 weeks. No participants will receive placebo.

• REC name

  North East - York Research Ethics Committee

• REC reference

  21/NE/0201

• Date of REC Opinion

  28 Jan 2022

• REC opinion

  Further Information Favourable Opinion