Facet Joint PainPhase 1NCT07520240
ITX24-01 in Adult Male and Female Patients With Select Types of Severe Chronic Neck- and Lower Back Pain
A Phase 1 study testing ITX24-01 and Normal Saline (0.9% NaCl) in people with Facet Joint Pain, run by Interventional AnalgesiX Inc. at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facet Joint Pain
- What is being tested?
- ITX24-01 and Normal Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jun 2026to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Sydney Pain Management Centre
Wahroonga, New South Wales, 2076
Vahid Mohabbati, M.D., +61 481 130 352, director@sydneypaincentre.com
Vahid Mohabbati, M.D.
About this study
Official title: A Sequential, Single Ascending Dose, Phase 1b, Randomised, Double-Blind, 2-Arm Study to Investigate the Safety and Tolerability of ITX24-01 Compared With Placebo In Adult Male and Female Patients With Select Types of Severe Chronic Neck- And Lower Back Pain
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.
Read the detailed description
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.
- Conditions
- Facet Joint Pain
- Being tested
- ITX24-01, Normal Saline (0.9% NaCl)
- Keywords
- chronic zygapophysial joint pain, chronic zygapophyseal joint pain, back pain, neck pain
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITX24-01Drug
Fluoroscopy guided local administration by the medial branch block (MBB) route. Dosage form: liquid. Frequency of administration: once (single dose).
Normal Saline (0.9% NaCl)Drug
Placebo (negative control). Dosage form: liquid. Frequency of administration: once (single dose).
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Dose Level 1. Dosage form: liquid. Frequency of administration: once (single dose). Receives: Drug: ITX24-01 |
| Intermediate Dose | Experimental | Dose Level 2. Dosage form: liquid. Frequency of administration: once (single dose). Receives: Drug: ITX24-01 |
| Full Dose | Experimental | Dose Level 3. Dosage form: liquid. Frequency of administration: once (single dose). Receives: Drug: ITX24-01 |
| Control | Placebo comparator | Negative control Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Participant responses collected via the Clinical Outcome Measurement Brief Instrument (COMBI) questionnaire.
Measured: During the screening period and at 6 weeks of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facet Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Interventional AnalgesiX Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520240
- Sponsor's protocol ID
- IAX25-001
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25312899
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential, Single Ascending Dose, Phase 1b, Randomised, Double-Blind, 2-Arm Study to Investigate the Safety and Tolerability of ITX24-01 Compared With Placebo In Adult Male and Female Patients With Select Types of Severe Chronic Neck- And Lower Back Pain
- ClinicalTrials.gov ID
- NCT07520240
- Acronym / sponsor ID
- IAX25-001
- Conditions
- Facet Joint Pain
- Keywords
- chronic zygapophysial joint pain, chronic zygapophyseal joint pain, back pain, neck pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Interventional AnalgesiX Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: ITX24-01Dose Level 1. Dosage form: liquid. Frequency of administration: once (single dose). |
| Intermediate Dose | Experimental | Drug: ITX24-01Dose Level 2. Dosage form: liquid. Frequency of administration: once (single dose). |
| Full Dose | Experimental | Drug: ITX24-01Dose Level 3. Dosage form: liquid. Frequency of administration: once (single dose). |
| Control | Placebo comparator | Drug: Normal Saline (0.9% NaCl)Negative control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITX24-01Fluoroscopy guided local administration by the medial branch block (MBB) route. Dosage form: liquid. Frequency of administration: once (single dose). | Drug | Full Dose, Intermediate Dose, Low dose |
| Normal Saline (0.9% NaCl)Placebo (negative control). Dosage form: liquid. Frequency of administration: once (single dose). | Drug | Control |
Primary outcome
Safety of ITX24-01 or placebo delivered locally by the medial branch block (MBB) route in adult participants with severe chronic zygapophysial joint pain
Time frame: During the screening period, on the day of ITX24-01 administration, and up to 6 weeks of follow-up.
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
Time frame: At pre-specified time points up to 6 hours after administration of the investigational medicinal product (IMP).
Pain at the injection site, assessed using a verbal response scale (VRS) from 0 (no pain) to 10 (worst pain).
1 secondary outcome
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
Time frame: During the screening period and at 6 weeks of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 25312899Stojanovic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITX24-01 and Normal Saline (0.9% NaCl) in people with Facet Joint Pain, run by Interventional AnalgesiX Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IAX Clinical Trials (5072695902, clinical@iax.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ITX24-01 or placebo delivered locally by the medial branch block (MBB) route in adult participants with severe chronic zygapophysial joint pain (time frame: During the screening period, on the day of ITX24-01 administration, and up to 6 weeks of follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07520240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.