The study is a single ascending dose (SAD), single-center, randomised, double-blind, placebo-controlled Phase 1b clinical trial designed to evaluate the safety, tolerability, and preliminary analgesic efficacy of ITX24-01 in patients with severe chronic zygapophysial joint pain (facet joint pain). The study consists of three dose escalation cohorts and one extension cohort.
Male or female. Women of childbearing potential must be willing to use contraceptives, or not be sexually active from the time when, during screening, pregnancy was excluded (by history and/or pregnancy test) until after the day of treatment has been completed (until ≥6 hours after administration of the IMP).
Age ≥18 years
Diagnosis of chronic zygapophysial joint neck- or lower back pain and elected to undergo medial branch neurotomy (MBN), aka radiofrequency ablation (RFA), as treatment for that pain syndrome. Participants can be patients who have undergone prior MBN (at the same level and side) and who have experienced pain recurrence and have, at the time of enrollment, opted for a repeat MBN procedure (at the same level and side). A positive MBB as determined by the Principal Investigator (PI) is required for all patients that was performed either at the time of the original diagnosis or at the time of pain recurrence. Thereby, for patients with a new diagnosis of chronic zygapophysial joint neck- or lower back pain (not treated with MBN in the past), a positive diagnostic MBB will be required. For patients with pain recurrence, a positive diagnostic MBB that was performed at the time of the original pain diagnosis, i.e., before the first MBN treatment, will be considered sufficient. (If no diagnostic MBB was performed at the time of the original diagnosis, a diagnostic MBB at the time of recurrence will be required.) The diagnosis will be reviewed by the Principal Investigator (PI) during Screening who will consider the timeline and diagnostic rigor of prior medical findings and tests in conjunction with the evaluation performed during screening (history and physical exam). PI agreement with the diagnosis (at their discretion) is required for the participant to meet this criterion.
Ambulatory
Pregnant or breastfeeding
Diagnosis of thoracic chronic zygapophysial joint pain
Allergy or hypersensitivity to lidocaine, bupivacaine or iodinated radiographic contrast media
Clinical history of angina, myocardial infarction or stroke experienced within the past year
Parallel
ITX24-01
DrugFluoroscopy guided local administration by the medial branch block (MBB) route. Dosage form: liquid. Frequency of administration: once (single dose).
Normal Saline (0.9% NaCl)
DrugPlacebo (negative control). Dosage form: liquid. Frequency of administration: once (single dose).
Safety of ITX24-01 or placebo delivered locally by the medial branch block (MBB) route in adult participants with severe chronic zygapophysial joint pain
Incidence and severity of adverse events (AEs) and their relatedness to the Investigational Medicinal Product (IMP) determined according to CTCAE (version 5.0).
Tolerability of ITX24-01 or placebo delivered locally by the medial branch block (MBB) route in adult participants with severe chronic zygapophysial joint pain
Pain at the injection site, assessed using a verbal response scale (VRS) from 0 (no pain) to 10 (worst pain).
Preliminary efficacy of a single dose of ITX24-01 or placebo administered via the medial branch block (MBB) route in patients with severe chronic zygapophysial joint pain
Participant responses collected via the Clinical Outcome Measurement Brief Instrument (COMBI) questionnaire.
Healthcare utilization of patients with severe chronic zygapophysial joint pain following a single dose of ITX24-01 or placebo administered via the medial branch block (MBB) route
Proportion of patients who proceed to medial branch nerve radiofrequency neurotomy (MBN).
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