RLS-0071 for Hypoxic-Ischemic Encephalopathy (STAR Trial)

Phase 2

Recruiting

Research Sponsored by ReAlta Life Sciences, Inc.

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 12, and 24 months

Summary

This trial studies a new drug to treat hypoxic-ischemic encephalopathy, a condition that affects 4-12k US people each year, and has a high mortality rate. It will evaluate safety and tolerability in newborns with moderate-severe HIE.

Who is the study for?

This trial is for newborns with moderate or severe brain injury due to lack of oxygen (HIE) who are undergoing cooling therapy. They must be from a single birth, at least 36 weeks gestation, and have specific signs of encephalopathy before cooling starts. Babies with serious bleeding in the brain, suspected infections, extreme low blood pressure unresponsive to drugs, major congenital issues, or other non-HIE related brain injuries cannot participate.

What is being tested?

The study tests RLS-0071's safety and ability to tolerate it as a potential treatment for HIE in newborns compared to a placebo. Newborns will either receive RLS-0071 or an inactive substance while they undergo therapeutic hypothermia—a standard treatment where the baby's body temperature is lowered to help heal the brain.

What are the potential side effects?

As this is an early-stage trial evaluating safety and tolerability, specific side effects of RLS-0071 are not yet fully known but may include reactions at the injection site, changes in vital signs like heart rate or blood pressure, allergic reactions or no side effects at all.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 12, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 12, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 12, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment group at Day 14

Frequency and severity of adverse events of special interest (AESIs) and SAEs by treatment group at 24 months

Frequency of premature discontinuation by treatment group due to AEs at Day 14

Secondary study objectives

Brain injury MRI score at Day 12 for the grey matter injury domain

Brain injury score at Day 12, as assessed through magnetic resonance imaging (MRI), using a standardized scoring system for the white matter injury domain

Early neonatal mortality at Day 14

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