Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase I/II, First-in-Human Study to Assess the Safety and Efficacy of Two Doses of SX600 Administered by Lumbosacral Transforaminal Epidural Injection in Patients With Radicular Pain Secondary to Lumbar Intervertebral Disc Herniation

This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable micro-suspension, SX600 at 12.5 mg or 25.0 mg) or Placebo (0.9% Sodium Chloride for Injection, BP) via transforaminal epidural injection to the lumbosacral epidural space.

Main Inclusion Criteria:

• Adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study
• Presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy.
• Mean Worst Daily Leg Pain score of ≥5.0 and ≤9.0
• Women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing

Main Exclusion Criteria:

• Documented history of allergy or intolerance to components of the Investigational Medicinal Product, relevant radiologic contrast media, or local anaesthetics
• Is pregnant or lactating
• Has been taking corticosteroid medications routinely in the past 6 months or has received an epidural corticosteroid injection within 12 weeks of screening
• Has a BMI greater than 40 kg/m2
• Has radiological evidence of clinically significant foraminal stenosis at L4-L5 or L5-S1 or of clinically significant spinal stenosis, or spondylolisthesis (Grade 2 or higher). (Note, asymptomatic foraminal stenosis at other spinal levels is not excluded).
• Has Diabetes Mellitus (Type 1 or Type 2)- prior confirmed HbA1c or OGTT
• Has a history of significant leg pain unrelated to disc herniation that would significantly compromise assessment of back or leg radicular pain
• Has had lumbar back surgery
• Has received an implantable device for pain management