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Monoclonal Antibodies

ELA026 for Hemophagocytic Lymphohistiocytosis

Phase 1

Recruiting

Research Sponsored by Electra Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All countries: ≥12 years at the time of HLH diagnosis (Cohort 1-4)

Relapsed refractory HLH. Participant is hospitalized with HLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up by week 12

Awards & highlights

Study Summary

This trialtests a new treatment for a rare, deadly syndrome caused by an overactive immune system. It will assess safety, efficacy, and pharmacology of the treatment.

Who is the study for?

This trial is for people aged 12 and older diagnosed with secondary hemophagocytic lymphohistiocytosis (HLH), a severe immune activation condition. Participants can be treatment-naive or have relapsed/refractory HLH, must meet specific diagnostic criteria, and be hospitalized. Those with primary HLH, uncontrolled conditions, recent investigational treatments or stem cell transplants are excluded.Check my eligibility

What is being tested?

The study tests ELA026, an antibody aimed at reducing inflammation caused by myeloid and T cells in patients with secondary HLH. It evaluates the safety and effectiveness of this drug as well as how it's processed by the body.See study design

What are the potential side effects?

Potential side effects of ELA026 may include reactions related to immune suppression such as increased risk of infections. Specific side effects are not listed but generally could involve issues due to interaction with the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was 12 years or older when diagnosed with HLH.

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I have HLH and meet most of the HLH-2004 criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ by week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~by week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and by week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]

Secondary outcome measures

Best Response to Treatment

Change from baseline in monocyte levels

Incidence of Anti-drug antibodies to ELA026

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ELA026Experimental Treatment1 Intervention

Cohort 1: Single dose escalation up to 3.0 mg/kg IV or SC Cohorts 2-4: dose, route, and frequency of administration (IV or SC) to be determined

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ELA026

2021

Completed Phase 1

~100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Electra Therapeutics Inc.Lead Sponsor

1 Previous Clinical Trials

91 Total Patients Enrolled

Medical DirectorStudy DirectorElecta Therapeutics Inc.

2,777 Previous Clinical Trials

8,064,195 Total Patients Enrolled

Media Library

ELA026 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05416307 — Phase 1

Hemophagocytic Lymphohistiocytosis Research Study Groups: ELA026

Hemophagocytic Lymphohistiocytosis Clinical Trial 2023: ELA026 Highlights & Side Effects. Trial Name: NCT05416307 — Phase 1

ELA026 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05416307 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is ELA026 a reliable treatment option with minimal risks?

"Due to the limited clinical data available, ELA026 was given a score of 1 on our safety scale. This is because it is currently in Phase 1 and has not been extensively tested for efficacy or safety yet."

Answered by AI

Is this study currently recruiting participants?

"Data available on clinicaltrials.gov attests that this medical trial is recruiting participants at the moment, with its initial posting having been made on May 19th 2022 and most recent edits conducted February 6th 2023."

Answered by AI

How many participants are included in this trial?

"Affirmative. The clinical trial is in the process of recruiting and data from clinicaltrials.gov corroborates this fact, with an initial post date of May 19th 2022 and a most recent update on February 6th 2023. 24 participants are needed to be enrolled across six medical sites."

Answered by AI

In what locales can one find the implementation of this medical trial?

"This medical trial is enrolling participants at 6 various sites, comprising of Los Angeles, Washington and Tampa among others. To ease the burden posed by travelling to a clinic for treatment, it would be beneficial to select one closest to you."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Safety and Efficacy of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis

2022. "Evaluation of the Safety and Efficacy of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05416307.