Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

A Phase 2b/3, Double-blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury.

Inclusion Criteria:

• Acute traumatic cervical SCI, motor level of C4, C5, C6, or C7 on each side:

  • Screening UEMS score must be ≤16 points on each side.
  • AIS A subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and T1 on at least 1 side.
  • AIS B subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and C7 on at least 1 side.

• American Spinal Injury Association Impairment Scale (AIS) grade A or AIS grade B.

• Scheduled and planned to undergo a spinal decompression/stabilization surgery that commences within 72 hours after the initial injury.

• Computed tomography (CT) scan or magnetic resonance imaging (MRI) is consistent with the subject's neurological deficit.

Exclusion Criteria:

• Participation in any other clinical study for acute SCI without approval by the sponsor.
• Inability to undergo decompression/stabilization surgery that commences within 72 hours after injury.
• One or more upper extremity muscle groups untestable during screening ISNCSCI examination.
• Acute SCI from gunshot or penetrating/stab wound; non-traumatic SCI (e.g., transverse myelitis, acute disc herniation); brachial plexus injury; complete spinal cord transection; or multifocal SCI.
• Females who are breastfeeding or have a positive serum pregnancy test.
• Body mass index (BMI) of ≥40 kg/m^2 at screening.
• History of an adverse reaction to a fibrin sealant or its components.
• Unconsciousness or other mental impairment that precludes reliable International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) examination.
• Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs.
• Any significant medical or psychiatric comorbidities that would significantly increase the risk of study enrollment and/or significantly interfere with study outcomes or assessments, in the judgment of the investigator.

Other protocol defined Inclusion/Exclusion criteria may apply.