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

NCT05196919 | Completed Phase 2 Results FDA Drug

• 1 other identifier: XT-150-1-0302
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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. 1.0.15 mg XT-150 (1.0 milliliter \[mL\] total delivered by two 0.5 mL injections)
2. 2.0.45 mg XT-150 (1.0 mL total delivered by two 0.5 mL injections)
3. 3.Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)

Conditions

Facet Joint Pain; Back Pain; Inflammation

Keywords

FJOA; Facetogenic Pain; Intra-articular Injection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Day 270

Secondary Outcomes (3)

• Change From Baseline in Oswestry Disability Index (ODI) Scores

  Day 270

• Change From Baseline in Patient Global Assessment (PGA) Scores

  Up to Day 270

• Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores

  Day 270

Study Arms (3)

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.

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.

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.

Biological: Placebo

Interventions

XT-150 BIOLOGICAL

XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.

0.15mg XT-150; 0.45mg XT-150

Placebo BIOLOGICAL

Phosphate-buffered saline for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Xalud Therapeutics, Inc.: lead

Study Sites (3)

Neurovations

Napa, California, 94558, United States

Location

Source HealthCare

Santa Monica, California, 90403, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Back Pain; Inflammation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Director of Medical Inquiries
• Organization: Xalud Therapeutics, Inc.

medical.information@xaludthera.com

212-301-6673

Study Officials

• Morgan Stokes

  Xalud Therapeutics

  STUDY DIRECTOR

• Howard Rutman, MD

  Xalud Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled, double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 19, 2022
• Study Start: February 24, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)