Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain (NCT05196919) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain
United States75 participantsStarted 2022-02-24
Plain-language 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 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).
1. 0.15 mg XT-150 (1.0 milliliter \[mL\] total delivered by two 0.5 mL injections)
2. 0.45 mg 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)
Who can participate
Age range18 Years â 90 Years
SexALL
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Inclusion criteria
â. Male or female, between 18 and 90 years of age, inclusive.
â. 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.
â. 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.
â. LBP (Low Back Pain) worsened by activity or motion of region
â. Have had a positive diagnostic facet pain block with lidocaine; admittance if participant gains 50% relief of pain within 30 minutes of test injection
â. 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.
â. 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).
What they're measuring
1
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Timeframe: Up to Day 270
2
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Timeframe: Up to Day 270
3
Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS)
â. 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.
Exclusion criteria
â. Hypersensitivity, allergy, or significant reaction to lidocaine or any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
â. Facet injection with corticosteroid in the past 6 months
â. Lumbar medial branch nerve ablation (e.g., by radiofrequency technique) within the past 12 months
â. 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
â. 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.)
â. Current treatment with immunosuppressive (systemic corticosteroid therapy \[equivalent to \>10 milligrams per day {mg/day} prednisone\] or other strong immunosuppressant)