Open-label Study of ELA026 in Participants with sHLH
Research type
Research Study
Full title
A Phase 2/3, Open-label, Single-arm, Multicenter, Historical Control Study to Evaluate ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
IRAS ID
1011759
Contact name
Crystal Browning
Contact email
Sponsor organisation
Electra Therapeutics, Inc
Eudract number
0000-000000-00
Research summary
Electra Therapeutics Inc. is running a research study to determine if a test medicine, not yet approved for market, named ELA026, will help in the treatment of Secondary Hemophagocytic Lymphohistiocytosis (sHLH) and to determine how safe it is to use in people with sHLH. sHLH is a life-threatening inflammatory condition that requires urgent treatment. Many patients become very sick from sHLH and require hospitalization. If adequate treatment is not given, complications like infection, bleeding, and organ failure can lead to death. “Secondary” HLH is generally associated with underlying medical conditions.The primary objective of the trial is to assess the effectiveness of ELA026 treatment in participants with cancer and lymphoma associated-sHLH.This is a phase 2/3, open label, single-arm clinical trial on ELA026 in participants with sHLH. Participants are expected to be treated with ELA026 for 12 weeks and complete a follow-up visit 4 weeks after the last treatment with ELA026. All participants will be followed for long term survival for up to two years. At the beginning of the treatment period, participants may need to be hospitalized. This study will include up to about 90 participants with sHLH (both male and female). his will be an open-label study (all participants will receive study treatment). The study treatments will be administered intravenously or subcutaneously. The study staff will closely monitor the health of the study participants throughout the study through physical examinations, vital signs, blood and urine tests. Participants will also undergo ultrasounds, ECGs, be asked about current medications and their health. Side effects associated with ELA026 include headache, redness and pain at the injection site, fatigue, fever, discomfort, chills, nausea, amongst others. Trial procedures might be associated with discomfort derived from blood sampling, ECG testing. Most/all these procedures are considered standard monitoring tools for patients.
REC name
Wales REC 2
REC reference
25/WA/0153
Date of REC Opinion
26 Jun 2025
REC opinion
Further Information Favourable Opinion