Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
NCT05416307 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2026-05-01
Summary
Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (mHLH), infection, or autoimmune disease). ELA026 is a fully human immunoglobulin G1 (IgG1) signal regulatory protein (SIRP)-directed monoclonal antibody designed to deplete the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with sHLH.
Conditions
- Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Interventions
- DRUG
-
ELA026
Multiple doses of ELA026
Sponsors & Collaborators
-
Electra Therapeutics Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Electra Therapeutics Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-19
- Primary Completion
- 2027-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
- Austria
- Germany
- Italy
- Netherlands
- Spain
- United Kingdom
Study Locations
More Related Trials
-
Tocilizumab and Hemophagocytic Lymphohistiocytosis (HLH)
NCT02007239 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis
NCT03312751 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)
NCT03311854 ·Status: COMPLETED ·Phase: PHASE2
-
Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH)
NCT06160791 ·Status: RECRUITING ·Phase: PHASE2
-
Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis
NCT04551131 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients
NCT05744063 ·Status: COMPLETED ·Phase: PHASE4
-
Omalizumab to Treat Hyper-IgE (Job's) Syndrome
NCT00260702 ·Status: COMPLETED ·Phase: PHASE1
-
INTO-HLH: A Disease Registry for Patients With Hemophagocytic Lymphohistiocytosis (HLH)
NCT05277272 ·Status: RECRUITING
-
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients
NCT03078582 ·Status: COMPLETED ·Phase: PHASE2
-
Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease
NCT03327857 ·Status: COMPLETED ·Phase: PHASE1
-
Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome
NCT00017862 ·Status: COMPLETED ·Phase: PHASE2
-
Cytokine Guided Risk Stratification and Treatment in Pediatric Hemophagocytic Lymphohistiocytosis
NCT05491304 ·Status: RECRUITING ·Phase: PHASE4
-
Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)
NCT03111628 ·Status: COMPLETED ·Phase: PHASE4
-
Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB
NCT05063110 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
NCT03030183 ·Status: COMPLETED ·Phase: PHASE2
-
Zanubrutinib for HLH
NCT05320575 ·Status: COMPLETED ·Phase: PHASE3
-
Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome
NCT00266565 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Dose-modified Emapalumab and Ruxolitinib (E-Ru) Regimens for Hemophagocytic Lymphohistiocytosis
NCT06951971 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
NCT00866788 ·Status: COMPLETED ·Phase: PHASE2
-
Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis
NCT04120090 ·Status: UNKNOWN ·Phase: PHASE3
-
Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
NCT06730126 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Individual Adult and Pediatric Patient Dose-escalated Interleukin-2 Therapy for Refractory Chronic GVHD
NCT02318082 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Anti-IgE in Chronic Urticaria
NCT00130234 ·Status: COMPLETED ·Phase: PHASE2
-
A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
NCT07190261 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients
NCT01333293 ·Status: COMPLETED ·Phase: PHASE2/PHASE3