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.
Purpose: This is a Single Ascending Dose (SAD), Phase 1b, single-center, randomised, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and preliminary analgesic efficacy of ITX24-01 administered via the medial branch block (MBB) route in patients with severe chronic zygapophysial joint pain (facet joint pain). The study consists of three dose escalation cohorts and one extension cohort. Study Population: The study population will consist of patients with severe chronic zygapophysial joint pain who meet the specified inclusion and exclusion criteria. Blinding and Masking: The study employs a double-blind design, where both participants and investigators are blinded to treatment assignments. Masking will be applied to the assessor, investigator, caregiver, and participant to minimize bias. Randomization and Assignment: Participants will be randomised within each cohort to receive either ITX24-01 or a placebo. In each of the three dose escalation cohorts (Group 1: low dose, Group 2: intermediate dose, Group 3: full dose), 6 participants will receive ITX24-01 and 2 will receive placebo. Group 4 is an extension cohort consisting of 4 participants receiving ITX24-01 and 4 receiving placebo. Randomization occurs after the screening period and before the treatment administration. Dose-Escalation and Monitoring: Progression from one dose group to the next will only be allowed if the Maximum Tolerated Dose (MTD) has not been reached in the preceding group. A Safety Monitoring Committee (SMC) overseeing safety data will also function as dose-escalation committee reviewing and approving dose increases or -adjustments between groups. If at any dose level an MTD was encountered, doses in subsequent groups will be adjusted. Extension Cohort: Group 4 serves as an extension cohort, in which additional patients will receive ITX24-01 at the highest dose level at which no MTD was encountered in any of the previous groups. Accordingly, the highest possible dose administered to participants in the extension cohort will be the full dose. If a dose modification (lowering) was instituted at any time in the study, the dose will be lower. The extension cohort will thereby further assess safety and tolerability at the highest dose reached during dose escalation. Dose Modification: If the MTD is reached in any group, the dose for the subsequent group (or any subsequently enrolled patients in the same group) will be lowered to the dose level of the preceding group, i.e., the preceding lower dose level, at which no MTD had been encountered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Fluoroscopy guided local administration by the medial branch block (MBB) route. Dosage form: liquid. Frequency of administration: once (single dose).
Placebo (negative control). Dosage form: liquid. Frequency of administration: once (single dose).
Sydney Pain Management Centre
Wahroonga, New South Wales, Australia
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).
Time frame: During the screening period, on the day of ITX24-01 administration, and up to 6 weeks of follow-up.
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).
Time frame: At pre-specified time points up to 6 hours after administration of the investigational medicinal product (IMP).
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.
Time frame: During the screening period and at 6 weeks of follow-up.
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