Facet Joint PainPhase 2NCT05196919
Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain
A Phase 2 study testing XT-150 in people with Facet Joint Pain and Back Pain, run by Xalud Therapeutics, Inc. at 3 sites in United States.
Trial summary
This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular glucocorticoid injection, or radiofrequency ablation of medial branches of the primary… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Facet Joint Pain, Back Pain, Inflammation
- 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
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Feb 2022to 20 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants are required to meet ALL of the following inclusion criteria:
- Male or female, between 18 and 90 years of age, inclusive.
- Sufficiently severe facet arthropathy of lumbar facets as determined by imaging (e.g., MRI, CT, X-ray, etc.) to establish an underlying basis of disease, as determined by usual bony and ligamentous signs of osteoarthritis (OA). Use of historical images permitted if obtained within the last 12 months.
- 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 in addition to mechanical pain and can be clinically distinguished by participant.
- LBP (Low Back Pain) worsened by activity or motion of region
- Have had a positive diagnostic facet pain block with lidocaine; admittance if participant gains 50% relief of pain within 30 minutes of test injection
Show all 15Show fewer
- Be free of local or intra-articular infection, tumor or other causes of localized LBP, for example, spondylolysis/pars defect, and adjacent vertebral body compression fracture based on imaging evaluation.
- Symptomatic disease because of osteoarthritis, established by imaging of facet joint and defined as a worst pain of at least 50 at the Screening Visit and the Baseline (Day 0) Visit (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. Participants who are not currently on any analgesics at the time of enrollment because they have discontinued prior analgesic therapy due to intolerance or lack of effect may be included. New analgesics or changes to the pre-established regimen during the study, with the exception of rescue medication use, are not permitted.
- Inadequate pain relief with prior therapies lasting 3 months or more.
- In the judgment of the Investigator, acceptable general medical condition
- Heterosexually active participants, male and female who are 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 read and understand study instructions, and willing and able to comply with all study procedures
Who cannot join
- Participants must NOT meet any of the following exclusion criteria:
- Hypersensitivity, allergy, or significant reaction to lidocaine or any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
- Facet injection with corticosteroid in the past 6 months
- Lumbar medial branch nerve ablation (e.g., by radiofrequency technique) within the past 12 months
- Prior lumbar fusion surgery
- Prior or existing medial branch nerve stimulation device (e.g., Mainstay device)
Show all 20Show fewer
- 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 >10 milligrams per day {mg/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
- 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 grams per deciliter [g/dL], <4.9 millimoles per liter [mmol/L], <80 g/L; transfusion indicated), Grade 1 white cell counts (lymphocytes <Lower limit of normal [LLN] - 800/cubic millimeters [mm^3]; <LLN - 0.8 x 10^9/L, neutrophils <LLN - 1500/mm^3; <LLN - 1.5 x 10^9/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. Participants, if medically feasible, can interrupt anticoagulant therapy by following local medical practice protocol for intra-articular injections for participants on anticoagulant, antiplatelet therapy.
- 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
3 sites in 1 country.
United States3 sites
Neurovations
Napa, California, 94558
Source HealthCare
Santa Monica, California, 90403
Center for Clinical Research
Winston-Salem, North Carolina, 27103
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
This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular 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 drug will be administered at Day 0 and Day 90 by bilateral intra-articular (IA) injection into the facet capsule, at the affected spinal level (e.g. Lumbar [L]3-4, L4-5, or L5-Sacrum [S]1) as determined by imaging (e.g., Magnetic resonance imaging [MRI], Computed tomography [CT]), X-ray, etc.) and physical exam.
Read more
Up to 72 participants will be randomized to placebo or one of two dose treatment groups (24 participants per treatment group).
- 0.15 mg XT-150 (1.0 milliliter [mL] total delivered by two 0.5 mL injections)
- 0.45 mg XT-150 (1.0 mL total delivered by two 0.5 mL injections)
- Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)
- Conditions
- Facet Joint Pain, Back Pain, Inflammation
- Being tested
- XT-150, Placebo
- Keywords
- FJOA, Facetogenic Pain, Intra-articular Injection
- Medical subject headings
- Back Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XT-150Biological
XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
PlaceboBiological
Phosphate-buffered saline for injection
| Study group | Role | What they receive |
|---|---|---|
| 0.15mg XT-150 | Experimental | 0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. Receives: Biological: XT-150 |
| 0.45mg XT-150 | Experimental | 0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. Receives: Biological: XT-150 |
| Placebo | Placebo comparator | Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
Measured: Up to Day 270
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Hematology and chemistry samples were only collected at Screening and not retested; therefore no results are available for those assessments Abnormal clinically significant physical examination findings were reported as adverse events, as applicable, and not separately reported.
Vital signs of temperature, heart rate, respiratory rate and blood pressure were collected at all visits throughout the study.
Measured: Up to Day 270
Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS)
The VAS is 0-100 scale which will be administered to participants via Electronic Patient Reported Outcome (ePRO) at each study visit. The participant will record his/her facet pain level on a scale from 0 (no pain) to 100 (worst pain). Higher scores indicate worse pain intensity.
Measured: Day 270
Secondary outcomes (3)
Change From Baseline in Oswestry Disability Index (ODI) Scores
The Oswestry Disability Index (ODI) is a 10-item questionnaire to quantify disability for acute or chronic low back pain. Each question is scored on a scale of 0 (least amount of disability) to 5 (most severe disability). Higher scores indicate severe disability.
Measured: Day 270
Change From Baseline in Patient Global Assessment (PGA) Scores
PGA is used to assess the current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). Higher score indicates worse symptoms.
Measured: Up to Day 270
Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores
The globally standardized and validated IPAQ - short form is used to measure self-reported physical activity levels. Four metabolic equivalent tasks (MET) - vigorous, moderate, walking and sitting were included to obtain the physical activity levels from the participants. A higher MET value indicates a higher physical activity level.
Measured: Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start24 Feb 2022
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xalud Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Morgan Stokes, Study director, Xalud TherapeuticsHoward Rutman, MD, Study director, Xalud Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196919
- Sponsor's protocol ID
- XT-150-1-0302
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2021
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. 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
- NCT05196919
- Acronym / sponsor ID
- XT-150-1-0302
- Conditions
- Facet Joint Pain, Back Pain, Inflammation
- Keywords
- FJOA, Facetogenic Pain, Intra-articular Injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Xalud Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular 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 drug will be administered at Day 0 and Day 90 by bilateral intra-articular (IA) injection into the facet capsule, at the affected spinal level (e.g. Lumbar [L]3-4, L4-5, or L5-Sacrum [S]1) as determined by imaging (e.g., Magnetic resonance imaging [MRI], Computed tomography [CT]), X-ray, etc.) and physical exam.
Up to 72 participants will be randomized to placebo or one of two dose treatment groups (24 participants per treatment group).
- 0.15 mg XT-150 (1.0 milliliter [mL] total delivered by two 0.5 mL injections)
- 0.45 mg XT-150 (1.0 mL total delivered by two 0.5 mL injections)
- Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.15mg XT-150 | Experimental | Biological: XT-1500.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. |
| 0.45mg XT-150 | Experimental | Biological: XT-1500.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. |
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 of lumbar facets as determined by imaging (e.g., MRI, CT, X-ray, etc.) to establish an underlying basis of disease, as determined by usual bony and ligamentous signs of osteoarthritis (OA). Use of historical images permitted if obtained within the last 12 months.
- 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 in addition to mechanical pain and can be clinically distinguished by participant.
- LBP (Low Back Pain) worsened by activity or motion of region
- Have had a positive diagnostic facet pain block with lidocaine; admittance if participant gains 50% relief of pain within 30 minutes of test injection
Key exclusion criteria (20 listed)
- Hypersensitivity, allergy, or significant reaction to lidocaine or any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
- Facet injection with corticosteroid in the past 6 months
- Lumbar medial branch nerve ablation (e.g., by radiofrequency technique) within the past 12 months
- Prior lumbar fusion surgery
- Prior or existing medial branch nerve stimulation device (e.g., Mainstay device)
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-150XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution. | Biological | 0.15mg XT-150, 0.45mg XT-150 |
| PlaceboPhosphate-buffered saline for injection | Biological | Placebo |
Primary outcome
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Time frame: Up to Day 270
Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Time frame: Up to Day 270
Hematology and chemistry samples were only collected at Screening and not retested; therefore no results are available for those assessments Abnormal clinically significant physical examination findings were reported as adverse events, as applicable, and not separately reported. Vital signs of temperature, heart rate, respiratory rate and blood pressure were collected at all visits throughout the study.
Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS)
Time frame: Day 270
The VAS is 0-100 scale which will be administered to participants via Electronic Patient Reported Outcome (ePRO) at each study visit. The participant will record his/her facet pain level on a scale from 0 (no pain) to 100 (worst pain). Higher scores indicate worse pain intensity.
3 secondary outcomes
Change From Baseline in Oswestry Disability Index (ODI) Scores
Time frame: Day 270
Change From Baseline in Patient Global Assessment (PGA) Scores
Time frame: Up to Day 270
Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores
Time frame: Day 270
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Morgan Stokes study director
Xalud Therapeutics
Howard Rutman, MD study director
Xalud Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XT-150 in people with Facet Joint Pain and Back Pain, run by Xalud Therapeutics, Inc. at 3 sites in United States.
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 20 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: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs (time frame: Up to Day 270). The study lists 3 primary outcomes in all. 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 15 Jan 2025.