ITX24-01 in Adult Male and Female Patients With Select Types of Severe Chronic Neck- and Lower Back Pain

NCT07520240 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IAX25-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facet Joint Pain

Keywords

chronic zygapophysial joint pain; chronic zygapophyseal joint pain; back pain; neck pain

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  At pre-specified time points up to 6 hours after administration of the investigational medicinal product (IMP).

Secondary Outcomes (1)

• 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

  During the screening period and at 6 weeks of follow-up.

Other Outcomes (1)

• 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

  Within 12 weeks post-treatment.

Study Arms (4)

Low dose

EXPERIMENTAL

Dose Level 1. Dosage form: liquid. Frequency of administration: once (single dose).

Drug: ITX24-01

Intermediate Dose

EXPERIMENTAL

Dose Level 2. Dosage form: liquid. Frequency of administration: once (single dose).

Drug: ITX24-01

Full Dose

EXPERIMENTAL

Dose Level 3. Dosage form: liquid. Frequency of administration: once (single dose).

Drug: ITX24-01

Control

PLACEBO COMPARATOR

Negative control

Drug: Normal Saline (0.9% NaCl)

Interventions

ITX24-01 DRUG

Fluoroscopy guided local administration by the medial branch block (MBB) route. Dosage form: liquid. Frequency of administration: once (single dose).

Full Dose; Intermediate Dose; Low dose

Normal Saline (0.9% NaCl) DRUG

Placebo (negative control). Dosage form: liquid. Frequency of administration: once (single dose).

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, an individual must meet all the following criteria:
• 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
• Body weight ≥48 kg
• Able to understand and comply with the study
• Willing to provide written informed consent
• Patients with zygapophysial joint neck- or lower back pain affecting a single joint (who require two injection of the IMP) are allowed in any group of the study (including Group 1). Patients with zygapophysial joint neck- or lower back pain affecting two joints at adjacent levels (who require three injection of the IMP) are allowed in Groups 2, 3 and 4 only.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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
• If taking warfarin, an INR ≥ 3.0
• Suicidal ideation or behavior (SIB)
• Pathological ECG. Exclude subjects with a marked baseline QTc prolongation defined as QTc \>470 ms in males or \>480 ms in females; or as QTc \>450 ms in males or \>470 ms in females with any additional torsades risk factors (heart failure, hypokalaemia, concomitant QT-prolonging drugs).
• Any other medical condition identified during screening that in the PI's judgement may preclude the safe performance of the study procedure
• For patients who are enrolled on the basis that they opt for repeat MBN procedure (at the same level and side), the prior MBN procedure must have been performed ≥6 months prior to enrollment.
• Zygapophysial joint neck- or lower back pain affecting- and requiring MBN of more than two joints or of more than one non-adjacent joint.

Sponsors & Collaborators

• Interventional AnalgesiX Inc.: lead

Study Sites (1)

Sydney Pain Management Centre

Wahroonga, New South Wales, 2076, Australia

Location

Related Publications (1)

• Stojanovic MP, Higgins DM, Popescu A, Bogduk N. COMBI: a convenient tool for clinical outcome assessment in conventional practice. Pain Med. 2015 Mar;16(3):513-9. doi: 10.1111/pme.12581. Epub 2014 Oct 14. No abstract available.

  PMID: 25312899 BACKGROUND

MeSH Terms

Conditions

Back Pain; Neck Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

IAX Clinical Trials

CONTACT

5072695902; clinical@iax.us

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)