Osteoarthritis, SpinePhase 1/2NCT04841512
Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis
A Phase 1/2 study testing XT-150 in people with Osteoarthritis, Spine, run by Xalud Therapeutics, Inc. at 1 site in Australia.
Trial summary
Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis, Spine
- What is being tested?
- XT-150
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2021to 1 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 90 years of age, inclusive.
- Sufficiently severe facet arthropathy (OA) of lumbar facets as determined by imaging, eg. CT or MRI, to establish an underlying basis of disease, as determined by usual bony and ligamentous signs of OA.
- Complaint of nociceptive, mechanical pain of lumbar spine, in particular pain localized to paramedian axis as opposed to midline or radicular. Radicular pain as a secondary finding may be allowed if it is addition to mechanical pain and can be clinically distinguished by subject
- Low Back Pain (LBP) worsened by activity or motion of region
- Have had a positive diagnostic facet pain block with lignocaine; admittance if subject gains 50% relief of pain within 30 minutes of test injection
- Be free of local or intra-articular infection, tumor or other causes of localized LBP, for example Including spondylolysis/pars defect, and adjacent vertebral body compression fracture based on MRI evaluation.
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- Symptomatic disease because of osteoarthritis, established by imaging of facet joint and defined as a worst pain of at least 40 at any time during the preceding week (based on scale of 0 to 100, with 100 representing "pain as bad as you can imagine") using Visual Analog Scale (VAS).
- Stable analgesic regimen during the 4 weeks prior to enrollment.
- Inadequate pain relief (minimum ≥50 mean on VAS with prior therapies lasting ≥3 months.
- In the judgment of the Investigator, acceptable general medical condition
- Male and female participants who are heterosexually active and not surgically sterile or post-menopausal must agree to use effective contraception, including abstinence, for the duration of the study and for 3 months after the study is completed
- Have suitable facet joint anatomy for intra-articular injection
- Willing and able to return for the follow-up (FU) visits
- Able to reliably provide pain assessment (FAST test score R2≥0.7)
- Able to read and understand study instructions, and willing and able to comply with all study procedures
Who cannot join
- Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
- Scheduled surgical procedure or nerve ablation to joint within the next 6 months; participant agrees not to schedule a surgical procedure, nerve ablation, or added facet injection within 6 months of study treatment
- High peri-operative risks which in the judgment of the investigator preclude a safe facet joint injection procedure (e.g. extreme obesity putting injection accuracy at risk, etc.)
- Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
- History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months.
- Currently receiving systemic chemotherapy or radiation therapy for malignancy
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- Clinically significant hepatic disease as indicated by clinical laboratory results ≥3 times the upper limit of normal for any liver function test (e.g., aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase)
- Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion indicated), Grade 1 white cell counts (lymphocytes <LLN - 800/mm3; <LLN - 0.8 x 109 /L, neutrophils <LLN - 1500/mm3; <LLN - 1.5 x 109 /L)
- Positive serology with reflex for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus within 4 weeks of commencing the study
- Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
- Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
- Current treatment with anticoagulants, other than low-dose aspirin
- Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
- Use of any investigational drug or device within 1 month before enrollment or current participation in a trial that included intervention with a drug or device; or currently participating in an investigational drug or device study.
- Any condition that, in the opinion of the Principal Investigator, could compromise the safety of the participant, the participant's ability to communicate with the study staff, or the quality of the data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain
Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine.
Read the detailed description
This is a Phase 1, safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint osteoarthritis (FJOA) and who are eligible for intra-synovial glucocorticoid injection, or radiofrequency ablation of medial branches of the primary dorsal ramus of the exiting nerve root, which innervates the adjacent facet joints.
- Conditions
- Osteoarthritis, Spine
- Being tested
- XT-150
- Keywords
- gene therapy, non-viral plasmid, osteoarthritis
- Medical subject headings
- Osteoarthritis, Spine, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XT-150Biological
non-viral Plasmid DNA encoding an IL-10 variant transgene
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sterile phosphate-buffered saline for injection Single 1mL injection into the facet joint Receives: Biological: XT-150 |
| XT-150 Dose #1 | Experimental | Lower dose of XT-150 sterile solution for injection Single 1 mL injection into the facet joint Receives: Biological: XT-150 |
| XT-150 Dose #2 | Experimental | Higher dose of XT-150 sterile solution for injection Single 1 mL injection into the facet joint Receives: Biological: XT-150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
0 - 100, 100 worst possible pain
Measured: 6 months
Secondary outcomes (1)
Oswestry Disability Index
10 dimensions, 0 - 5 score in each, with 5 as worst score in a dimension
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study startOct 2021 (estimated)
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Why it stopped: COVID - Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, SpineStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xalud Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841512
- Sponsor's protocol ID
- XT-150-1-0301
- Status last verified
- Mar 2022
- First submitted
- 7 Apr 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. All patient records are de-identified
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT04841512
- Acronym / sponsor ID
- XT-150-1-0301
- Conditions
- Osteoarthritis, Spine
- Keywords
- gene therapy, non-viral plasmid, osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID - Lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xalud Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 12 Apr 2021 (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.
Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine.
Detailed description
This is a Phase 1, safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint osteoarthritis (FJOA) and who are eligible for intra-synovial glucocorticoid injection, or radiofrequency ablation of medial branches of the primary dorsal ramus of the exiting nerve root, which innervates the adjacent facet joints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: XT-150Sterile phosphate-buffered saline for injection Single 1mL injection into the facet joint |
| XT-150 Dose #1 | Experimental | Biological: XT-150Lower dose of XT-150 sterile solution for injection Single 1 mL injection into the facet joint |
| XT-150 Dose #2 | Experimental | Biological: XT-150Higher dose of XT-150 sterile solution for injection Single 1 mL injection into the facet joint |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female, between 18 and 90 years of age, inclusive.
- Sufficiently severe facet arthropathy (OA) of lumbar facets as determined by imaging, eg. CT or MRI, to establish an underlying basis of disease, as determined by usual bony and ligamentous signs of OA.
- Complaint of nociceptive, mechanical pain of lumbar spine, in particular pain localized to paramedian axis as opposed to midline or radicular. Radicular pain as a secondary finding may be allowed if it is addition to mechanical pain and can be clinically distinguished by subject
- Low Back Pain (LBP) worsened by activity or motion of region
- Have had a positive diagnostic facet pain block with lignocaine; admittance if subject gains 50% relief of pain within 30 minutes of test injection
Key exclusion criteria (15 listed)
- Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
- Scheduled surgical procedure or nerve ablation to joint within the next 6 months; participant agrees not to schedule a surgical procedure, nerve ablation, or added facet injection within 6 months of study treatment
- High peri-operative risks which in the judgment of the investigator preclude a safe facet joint injection procedure (e.g. extreme obesity putting injection accuracy at risk, etc.)
- Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
- History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months.
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 |
|---|---|---|
| XT-150non-viral Plasmid DNA encoding an IL-10 variant transgene | Biological | Placebo, XT-150 Dose #1, XT-150 Dose #2 |
Primary outcome
Visual analog scale (VAS)
Time frame: 6 months
0 - 100, 100 worst possible pain
1 secondary outcome
Oswestry Disability Index
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No. Not applicable. All patient records are de-identified
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XT-150 in people with Osteoarthritis, Spine, run by Xalud Therapeutics, 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 15 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 Mar 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2022.