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New treatment option for Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Official title Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
ClinicalTrials.gov ID: NCT05416307
What this study is testing
What is ELA026?
ELA026 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for secondary hemophagocytic lymphohistiocytosis (shlh).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Key for Part 1:
- ≥12 years at the time of HLH diagnosis (Cohort 1).
- ≥6 years at the time of HLH diagnosis (Cohort 2-3).
- Treatment naïve or relapsed/refractory (Cohorts 1 and 2).
- Treatment naïve or early refractory (Cohort 3).
You likely can't join if
- for Part 1:
- Known or previous treatment for primary HLH
- Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
- Unknown trigger for sHLH
- Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
- Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days of the first dose of ELA026.
See the full eligibility criteria
- Key for Part 1:
- ≥12 years at the time of HLH diagnosis (Cohort 1).
- ≥6 years at the time of HLH diagnosis (Cohort 2-3).
- Treatment naïve or relapsed/refractory (Cohorts 1 and 2).
- Treatment naïve or early refractory (Cohort 3).
- Participant with sHLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria. Key for Part 2:
- Cohort A: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH.
- Cohort B: Adults with newly diagnosed, treatment-naïve, non-malignancy-associated sHLH.
- Cohort B: Adults with newly diagnosed, treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index.
- Cohort B: 13 to 17 years olds with newly diagnosed, treatment-naïve sHLH.
- Cohort B: 6 to 12 year olds, with refractory sHLH (safety lead-in cohort).
- Cohort B: 6 to 12 year olds, with newly diagnosed, treatment-naïve sHLH (after completion of safety lead-in cohort). Key
- for Part 1:
- Known or previous treatment for primary HLH
- Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
- Unknown trigger for sHLH
- Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
- Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days of the first dose of ELA026.
- Ongoing administration of any therapies used to treat HLH (excluding dexamethasone)
- Live or attenuated vaccine received within 6 weeks or bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening Key Exclusion Criteria for Part 2:
- Refractory sHLH (except for the safety lead-in cohort for 6-12 year olds in Cohort B).
- Known or suspected primary or hereditary HLH.
- Severe organ dysfunction.
- Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures.
- End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH.
- Allogeneic hemopoietic stem cell transplant within 100 days prior to the first dose of ELA026.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- St. Petersburg, Florida, United States
- Atlanta, Georgia, United States
- Rockville, Maryland, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Innsbruck, Austria
- Vienna, Austria
- Jena, Thuringia, Germany
- Villingen-Schwenningen, Germany
- Florence, Italy
- Genova, Italy
- Milan, Italy
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Washington D.C., District of Columbia, United States; St. Petersburg, Florida, United States; Atlanta, Georgia, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.