All studies
RecruitingPHASE2, PHASE3INTERVENTIONAL

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

This research is looking into a new treatment, ELA026, for a rare but serious immune system problem called secondary Hemophagocytic Lymphohistiocytosis (sHLH). This condition causes the immune system to become overactive. ELA026 is designed to help calm down this overactive immune response by targeting specific cells. The study aims to understand if ELA026 is safe, how well it works, and how the body uses it. We are particularly looking for adults and children (aged 6 and up) who have been recently diagnosed with sHLH, especially if it's linked to cancer. There's also some interest in those with sHLH not caused by cancer. The study is split into parts, with one part currently recruiting new participants.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
Electra Therapeutics Inc.
Enrolment target
156
Start
19 May 2022
Estimated completion
01 Jun 2029

What is this study about?

This study is investigating a new medication called ELA026 for a serious condition known as secondary Hemophagocytic Lymphohistiocytosis, or sHLH. This condition happens when your immune system, which normally fights off infections, becomes overactive and starts attacking your own healthy cells. This can lead to serious health problems. sHLH is often triggered by other conditions like cancer, severe infections, or autoimmune diseases.

ELA026 is a special type of medicine designed to calm down this overactive immune system. It works by targeting specific immune cells that are causing the inflammation. The main goals of this study are to understand if ELA026 is safe for people with sHLH, how well it helps control the condition, and how the medicine moves through and acts within the body. We hope to find a new and effective way to treat sHLH.

The study is divided into two main parts. One part has already finished enrolling participants. The second part, called SURPASS, is currently looking for new participants. This part is focused on newly diagnosed adults and children (aged 6 to 17) with sHLH, particularly those whose condition is linked to cancer. It also includes some participants where the sHLH is not caused by cancer. This research is important because it could lead to new treatment options for this challenging condition.

Key takeaways

  • This study is testing a new medicine called ELA026 for a serious immune condition (sHLH).
  • It aims to find out if ELA026 is safe and effective in treating sHLH.
  • The study is currently recruiting newly diagnosed adults and children (ages 6+) with sHLH.
  • Participation involves receiving the medicine and regular health check-ups.
  • You can stop taking part at any time without affecting your future medical care.

Who may be eligible?

To be considered for this study, you would generally need to have secondary Hemophagocytic Lymphohistiocytosis (sHLH). For the part of the study currently recruiting, we are looking for adults who have been recently diagnosed with sHLH, especially if it's connected to cancer. We are also interested in adults with newly diagnosed sHLH not caused by cancer, and teenagers aged 13 to 17 with newly diagnosed sHLH.

There's also a specific group for children aged 6 to 12. Initially, this group is for those whose sHLH has not responded well to other treatments. Once that first group is complete, we'll be looking for 6 to 12-year-olds who have been newly diagnosed with sHLH.

There are also some reasons why you might not be able to join. For example, if you have a different type of HLH (called primary or hereditary HLH), or if your sHLH has not fully responded to previous treatments (unless you are in the specific 6-12 year old group mentioned). Also, if you have very severe problems with your organs or other significant health conditions that might make taking part unsafe, you might not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 6 years old or older?
  2. Have you been diagnosed with secondary Hemophagocytic Lymphohistiocytosis (sHLH)?
  3. Is your sHLH newly diagnosed (in most cases)?
  4. Do you have any other serious medical conditions that might prevent you from joining a study?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the new medication, ELA026. This medicine will be given either through a drip into your vein (intravenously) or as an injection under your skin (subcutaneously). The study involves regular visits to the clinic for check-ups, blood tests, and other assessments to monitor your health and how the medicine is working. These visits help the study team understand the safety and effectiveness of ELA026. The total duration of your participation will depend on the specific part of the study you are in, and whether the treatment is helpful for you. You would have ongoing follow-up to track your progress.

Potential risks and benefits

Participating in this study might offer the chance to receive a new treatment for your sHLH that is not yet widely available. While we hope ELA026 will be effective, there's no guarantee it will work for everyone, and it might not be better than existing treatments. Like all medicines, ELA026 could have side effects, which the study team will discuss with you in detail. You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (41)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama at Birmingham School of Medicine
    Verified postcode
    Birmingham, United States· Recruiting
  • Phoenix Children's Hospital
    Verified postcode
    Phoenix, United States· Active not recruiting
  • University of California, Los Angeles
    Verified postcode
    Los Angeles, United States· Active not recruiting
  • MedStar Georgetown University Hospital
    Verified postcode
    Washington D.C., United States· Recruiting
  • Johns Hopkins All Children's Hospital
    Verified postcode
    St. Petersburg, United States· Recruiting
  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
    Verified postcode
    Atlanta, United States· Recruiting
  • Emory University
    Verified postcode
    Atlanta, United States· Recruiting
  • National Institute of Allergy and Infectious Diseases (NIAID)
    Verified postcode
    Rockville, United States· Recruiting
  • Columbia University
    Verified postcode
    New York, United States· Recruiting
  • Cornell University
    Verified postcode
    New York, United States· Recruiting
  • Hackensack University Medical Center
    Verified postcode
    New York, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting

Common questions

What is sHLH?

sHLH, or secondary Hemophagocytic Lymphohistiocytosis, is a rare but serious condition where your immune system becomes overactive and can damage healthy cells.

What is ELA026?

ELA026 is a new medicine being tested. It's designed to help calm down the overactive immune system in people with sHLH.

Who can take part in this study?

Generally, adults and children aged 6 and above with newly diagnosed sHLH may be eligible, especially if it's linked to cancer. There are specific criteria depending on your age and health condition.

What does 'treatment-naïve' mean?

It means you haven't received specific treatments for your sHLH before joining the study.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Clinical Trials

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Open-label Study of ELA026 in Participants With Secondary He…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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