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Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04841512
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : October 25, 2021
Information provided by (Responsible Party):
Xalud Therapeutics, Inc.

Brief Summary:
Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Spine Biological: XT-150 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Unblinded pharmacy, blinded clinical staff for administration and assessments
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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Placebo Comparator: Placebo
Sterile phosphate-buffered saline for injection Single 1mL injection into the facet joint
Biological: XT-150
non-viral Plasmid DNA encoding an IL-10 variant transgene

Experimental: XT-150 Dose #1
Lower dose of XT-150 sterile solution for injection Single 1 mL injection into the facet joint
Biological: XT-150
non-viral Plasmid DNA encoding an IL-10 variant transgene

Experimental: XT-150 Dose #2
Higher dose of XT-150 sterile solution for injection Single 1 mL injection into the facet joint
Biological: XT-150
non-viral Plasmid DNA encoding an IL-10 variant transgene

Primary Outcome Measures :
  1. Visual analog scale (VAS) [ Time Frame: 6 months ]
    0 - 100, 100 worst possible pain

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 6 months ]
    10 dimensions, 0 - 5 score in each, with 5 as worst score in a dimension

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  1. Male or female, between 18 and 90 years of age, inclusive.
  2. 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.
  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 addition to mechanical pain and can be clinically distinguished by subject
  4. Low Back Pain (LBP) worsened by activity or motion of region
  5. Have had a positive diagnostic facet pain block with lignocaine; admittance if subject 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 Including spondylolysis/pars defect, and adjacent vertebral body compression fracture based on MRI evaluation.
  7. 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).
  8. Stable analgesic regimen during the 4 weeks prior to enrollment.
  9. Inadequate pain relief (minimum ≥50 mean on VAS with prior therapies lasting ≥3 months.
  10. In the judgment of the Investigator, acceptable general medical condition
  11. 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
  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 reliably provide pain assessment (FAST test score R2≥0.7)
  15. Able to read and understand study instructions, and willing and able to comply with all study procedures

Exclusion Criteria:

  1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
  2. 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
  3. 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.)
  4. Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
  5. History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months.
  6. Currently receiving systemic chemotherapy or radiation therapy for malignancy
  7. 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)
  8. 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)
  9. Positive serology with reflex for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus within 4 weeks of commencing the study
  10. Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
  11. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
  12. Current treatment with anticoagulants, other than low-dose aspirin
  13. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
  14. 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.
  15. 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 identifier (NCT number): NCT04841512

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Contact: Flavia Cicuttini, MD +61 3 9903 0158

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Australia, Victoria
Alfred Health Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Flavia Cicuttini, MD    +61 3 9903 0158   
Contact: Anita Wluka, PhD, FRACP, MBBS    T: +61 3 9903 0994   
Principal Investigator: Flavia Cicuttini, MD         
Sponsors and Collaborators
Xalud Therapeutics, Inc.
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Responsible Party: Xalud Therapeutics, Inc. Identifier: NCT04841512    
Other Study ID Numbers: XT-150-1-0301
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not applicable. All patient records are de-identified

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Xalud Therapeutics, Inc.:
gene therapy
non-viral plasmid
Additional relevant MeSH terms:
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Osteoarthritis, Spine
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Bone Diseases