A Phase 2, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of EL219 Versus Standard of Care (Liposomal Amphotericin B Followed by Voriconazole) for Early Antifungal Therapy of Suspected Invasive Mould Infections

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to determine if EL219 is safe and effective compared to the standard of care for early treatment of suspected invasive mould infection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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∙ Participants who meet ALL the following inclusion criteria will be eligible to participate in the study:

• Willing and able to provide written informed consent.

• Males or females 18 years and older,

• Are at risk for invasive fungal infections (IFIs), with one of the following:

‣ Receipt of a bone marrow transplant (BMT) from an allogeneic donor, with blood, bone marrow, or cord blood as stem cell source.

⁃ Receiving or have recently (within 1 month) received cytotoxic, biologic, or immune modulating therapy(ies) for hematological malignancy.

⁃ Receipt of corticosteroids at mean minimum doses of 0.3 mg/kg/day prednisone equivalent for more than 3 weeks.

⁃ Receipt of other recognized T-cell immunosuppressants, such as cyclosporin, tumor necrosis factor alpha (TNF-α) blockers, or specific monoclonal antibodies during the last 3 months.

⁃ Inherited severe immunodeficiency

∙ Has suspected invasive mould infection (IMI) as defined by one or both of the following:

• Results of an assay having regulatory clearance in Europe or the United States (Conformité Européene \[CE\] mark or United States Food and Drug Administration \[US FDA\] 510k clearance), demonstrating positivity at validated cut-off that is suggestive of IMI, but does not meet microbiologic criteria for probable invasive aspergillosis (IA; as defined by European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group \[EORTC/MSG\]). Diagnostic tests must have regulatory approval in the region in which the diagnostic is performed and are inclusive of Platelia serum galactomannan, serum or bronchoalveolar lavage (BAL) polymerase chain reaction (PCR), serum or BAL Aspergillus antigen lateral flow assays (LFAs; IMMY, OLM Diagnostics, or TECO®), or urine MycoMEIA®-Aspergillus assay

• Abnormal findings on chest computed tomography (CT) scan without alternative microbiologic diagnosis Note: If CT of the chest is used to establish eligibility it must be performed within 7 days prior to randomization.

• 5\. Must have IV access in place or to be placed prior to beginning IV study therapy.

• 6\. Must be willing to adhere to dosing, study visit schedule, and mandatory diagnostic procedures.

• 7\. Female participants must meet 1 of the following criteria: A woman of childbearing potential (WOCBP) must agree to use a highly effective, preferably user-independent method of contraception (failure rate of \<1% per year when used consistently and correctly) for at least 30 days prior to screening and agree to remain on a highly effective method until 2 months after study drug administration.

• 8\. A WOCBP must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before study drug administration.

• 9\. Females must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 2 months after study drug administration.

• 10\. Male participants must be vasectomized or agree to abstain from intercourse or if engaging in sexual activity that has risk of pregnancy, must agree to use a double barrier method and agree not to donate sperm during the study and for at least 120 days after study drug administration.

Locations
United States
Texas
U. of Texas, MD Anderson
RECRUITING
Houston
Contact Information
Primary
Laura A. Navalta
info@eliontx.com
443-423-1785
Backup
Gordana Schnider, MHA
info@eliontx.com
443-423-1785
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2026-11
Participants
Target number of participants: 80
Treatments
Experimental: EL219
Participants randomized to EL219 will receive a single loading dose of EL219 at 2 mg/kg via IV infusion on Day 1, and 1.5 mg/kg IV infusions on Days 8, 15, 22, 29, and 36.~To maintain the blind, placebo IV infusions will be administered on Days 2-7 and 9-14 corresponding to Liposomal Amphotericin B (LAmB) dosing; thereafter, twice daily oral or IV placebo will be administered corresponding to voriconazole dosing until Day 42/EOT.
Active_comparator: Antifungal Comparator
Standard of Care- Participants will receive LAmB 3 mg/kg IV infusions for at least 14 days and up to 42 days.Voriconazole Daily Dosing- Loading 6 mg/kg via IV infusion every 12 hrs for the first 24 hrs. Post-loading: 4 mg/kg oral every 12 hrs (admin as 50 mg overencapsulated tabs) OR 4 mg/kg via IV infusion every 12 hrs~Participants on oral therapy will be administered placebo IV infusions corresponding to EL219 on Days 15, 22, 29, and 36 to maintain the blind. Participants may switch from LAmB to voriconazole (oral or IV) at any time, if any of the following occur:~* Dx. of proven or probable IA per EORTC/MSG criteria~* Other proven or probable susceptible MI~* Possible IMI that requires continued antifungal therapy~* Toxicity: Acute renal injury, hypokalemia or hypomagnesemia uncontrolled with IV supplementation, Increase in ALT to 3× baseline and/or total serum bilirubin 3× baseline, Intractable IRR~* Change to oral due to imminent hosp. discharge
Sponsors
Leads: Elion Therapeutics, Inc.

This content was sourced from clinicaltrials.gov