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

Phase 2

Completed

• Conditions: Facet Joint Pain; Back Pain; Inflammation
• Interventions: Biological: XT-150; Biological: Placebo

• Registration Number: NCT05196919
• Lead Sponsor: 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 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Study Start: 2022-02-24
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Results First Submitted: 2024-12-03
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Results First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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. 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.
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. Participants, if medically feasible, can interrupt anticoagulant therapy by following local medical practice protocol for intra-articular injections for participants on anticoagulant, antiplatelet therapy.
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.45mg XT-150	XT-150	0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo	Placebo	Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
0.15mg XT-150	XT-150	0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs	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	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)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Oswestry Disability Index (ODI) Scores	Day 270	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.
Change From Baseline in Patient Global Assessment (PGA) Scores	Up to Day 270	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.
Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores	Day 270	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.

Trial Locations

Locations (3)

Neurovations; 🇺🇸 Napa, California, United States

Source HealthCare; 🇺🇸 Santa Monica, California, United States

Center for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States