Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Conditions

• Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ELA026 — DRUG
  Multiple doses of ELA026

Study Details

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.

Key Dates

Start date

May 19, 2022

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2029

Study Design

Enrollment

156 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 ELA026
  Cohort 1: Single dose escalation up to 3.0 mg/kg IV or SC. Cohort 2: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Day 2 - 4, followed by weekly maintenance doses of 1 mg/kg IV/SC from Day 8 to Day 81. Cohort 3: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Days 2 - 4, followed by twice weekly maintenance doses of 0.5 mg/kg IV/SC from Day 8 to Day 81.
• Experimental: Part 2 ELA026
  Cohort A and Cohort B: priming dose: 0.1 mg/kg IV on Day 1; loading dose 0.3 mg/kg IV on Days 2- 4, followed by twice weekly maintenance doses of 0.5 mg/kg (IV/SC) from Day 8 to Day 81.

Primary Outcome Measure

Part 1: Number of Participant with Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and tolerability] [ Time Frame: Up to Week 12 ]

Central Contacts

• Clinical Trials
  Please email
  [email protected]

Locations (18)

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