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Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT05196919
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Xalud Therapeutics, Inc.

Brief 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 dorsal ramus of the exiting nerve root, which innervates the adjacent facet joints.

Study drug will be administered 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 60 participants will be randomized to placebo or one of two dose treatment groups (20 participants per treatment group).

  1. 150 micrograms (µg) XT-150 (1.0 milliliters [mL] total delivered by two 0.5 mL injections)
  2. 450 µg XT-150 (1.0 mL total delivered by two 0.5 mL injections)
  3. Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)

Safety parameters and efficacy endpoints will be evaluated at Baseline, Day 7, Day 14, Day 30, and approximately monthly through 180 days (±14 days) from the injection date.


Condition or disease Intervention/treatment Phase
Facet Joint Pain Back Pain Inflammation Biological: XT-150 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo controlled, double blind
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT- 150 for the Treatment of Facet Joint Osteoarthritis Pain
Actual Study Start Date : February 24, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 150 µg XT-150
150 µg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections at week 0.
Biological: XT-150
XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.

Experimental: 450 µg XT-150
450 µg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections at week 0.
Biological: XT-150
XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.

Placebo Comparator: Placebo
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections at week 0.
Biological: Placebo
Phosphate-buffered saline for injection




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events after an intra-articular dose of study drug (XT-150 or Placebo) [ Time Frame: Day 0 to day 180 ]
    Adverse events will be collected and recorded in the electronic Case report form (eCRF) throughout the duration of the trial.


Secondary Outcome Measures :
  1. Change from baseline in low back pain intensity [ Time Frame: Day 180 ]
    Pain intensity will be on a 0-100 Visual Analog Scale of Pain Intensity (VAS).


Other Outcome Measures:
  1. Change from baseline in back disability [ Time Frame: Day 180 ]
    Back disability assessed using the Oswestry Disability Questionnaire. 0 percent(%)-100 disability scale

  2. Change from baseline on self-reported physical activity [ Time Frame: Day 180 ]
    Self reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ short form) High-Moderate-Low categories

  3. Change from baseline on Quality of Life [ Time Frame: Day 180 ]
    Quality of Life assessed using the Short Form Health Survey (SF12)physical and mental components. Scores range from 0-100, with higher scores indicating better physical and mental health.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants are required to meet ALL of the following inclusion criteria:

  1. Male or female, between 18 and 90 years of age, inclusive.
  2. 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.
  3. 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.
  4. LBP (Low Back Pain) worsened by activity or motion of region
  5. Have had a positive diagnostic facet pain block with lidocaine; admittance if participant gains 50% relief of pain within 30 minutes of test injection
  6. 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.
  7. 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).
  8. Stable analgesic regimen during the 4 weeks prior to enrollment.
  9. Inadequate pain relief with prior therapies lasting 3 months or more.
  10. In the judgment of the Investigator, acceptable general medical condition
  11. 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
  12. Have suitable facet joint anatomy for intra-articular injection
  13. Willing and able to return for the follow-up (FU) visits
  14. Able to read and understand study instructions, and willing and able to comply with all study procedures

Exclusion Criteria:

Participants must NOT meet any of the following exclusion criteria:

  1. Hypersensitivity, allergy, or significant reaction to lidocaine or any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
  2. Facet injection with corticosteroid in the past 6 months
  3. Lumbar medial branch nerve ablation (e.g., by radiofrequency technique) within the past 12 months
  4. Prior lumbar fusion surgery
  5. Prior or existing medial branch nerve stimulation device (e.g., Mainstay device)
  6. 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
  7. 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.)
  8. Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent to >10 milligrams per day {mg/day} prednisone] or other strong immunosuppressant)
  9. History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months.
  10. Currently receiving systemic chemotherapy or radiation therapy for malignancy
  11. 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)
  12. 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)
  13. Positive serology with reflex for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus within 4 weeks of commencing the study
  14. Significant neuropsychiatric conditions, dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
  15. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
  16. Current treatment with anticoagulants, other than low-dose aspirin
  17. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
  18. 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.
  19. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05196919


Contacts
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Contact: Perry Tresh, BS 646 459 4250 ptresh@xaludthera.com

Locations
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United States, California
Neurovations Recruiting
Napa, California, United States, 94558
United States, North Carolina
Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Xalud Therapeutics, Inc.
Investigators
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Study Director: Perry Tresh, BS Xalud Therapeutics
Study Director: Howard Rutman, MD Xalud Therapeutics
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Responsible Party: Xalud Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05196919    
Other Study ID Numbers: XT-150-1-0302
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xalud Therapeutics, Inc.:
FJOA
Facetogenic Pain
Intra-articular Injection
Additional relevant MeSH terms:
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Osteoarthritis
Arthralgia
Inflammation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Pain
Neurologic Manifestations