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Phase 3 Evaluation of Sovateltide for the Treatment of Acute Traumatic Brain Injury

ConditionTraumatic Brain Injury
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPharmazz, Inc.

About this trial

The study has been designed to advance sovateltide (IRL-1620) into a pivotal Phase III clinical trial for acute traumatic brain injury (TBI). With millions affected annually and zero approved neuroprotective pharmacotherapies available, this milestone marks a critical step forward in addressing one of modern medicine's greatest unmet needs. By harnessing our proprietary neural repair discovery platform, sovateltide targets the cascade of secondary cell death while stimulating neurogenesis and angiogenesis. Building on the strong momentum of our ongoing global Phase III RESPECT-ETB study in acute ischemic stroke, this study will further validate the broad therapeutic potential of our endothelin-B receptor platform across severe acute neurovascular conditions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male or female aged 18-90 years

Consent must be obtained prior to any study-specific procedure from the participant or, if the participant lacks capacity to provide informed consent, from the participant's Legally Authorized Representative (LAR), in accordance with applicable law and IRB requirements.

Clinical diagnosis of closed traumatic brain injury (TBI), classified as moderate to severe, with a post-resuscitation Glasgow Coma Scale (GCS) score of 5 to 13, inclusive, at screening (moderate TBI: GCS 9-13; eligible severe TBI range: GCS 5-8).

Radiological confirmation of TBI on neuroimaging (diffuse injury II-V, Marshall's CT Classification).

Disqualifiers

TBI caused by penetrating injury (e.g., gunshot wound) rather than blunt trauma.

Isolated epidural hematoma.

Suspected or confirmed spinal cord injury.

Severe cardiac or hemodynamic instability prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    The reference product is a matching placebo for sovateltide. It is a sterile lyophilized injection consisting of excipients formulated without the active ingredient in a 5.0 mL vial, to be reconstituted in 5 mL of normal saline (0.9% Sodium Chloride Injection).

  • Sovateltide

    Drug

    The test product is sovateltide. It is available as a lyophilized injection containing 30 μg of sovateltide in a 5.0 mL vial, to be reconstituted in 5 mL normal saline (0.9% Sodium Chloride Injection).

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: The reference product is a matching placebo for sovateltidePlacebo comparator 1 intervention
Group B: The test product is sovateltideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients achieving a favorable functional outcome (GOS-E score ≥7) at Day 90 post-randomization.

Time frame
90 days

Secondary outcomes

1

Proportion of patients achieving a favorable functional outcome (GOS-E score ≥7) at Day 180 post-randomization.

Time frame
180 days
2

Proportion of patients achieving a favorable functional outcome (GOS-E score ≥7) at Days 30 post-randomization.

Time frame
30 days
3

Proportion of patients with an improvement in Disability Rating Scale (DRS) to less than or equal to 3 at Days 30, 90, and 180 post randomization.

Time frame
180 days
4

Change in the Montreal Cognitive Assessment (MoCA) at Days 30, 90, and 180 post-randomization.

Time frame
180 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharmazz, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: