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

NCT05196919 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-01-15

Study results available
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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)

Conditions

Interventions

BIOLOGICAL

XT-150

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

BIOLOGICAL

Placebo

Phosphate-buffered saline for injection

Sponsors & Collaborators

  • Xalud Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Morgan Stokes · Xalud Therapeutics

  • Howard Rutman, MD · Xalud Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2023-09-20
Completion
2023-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196919 on ClinicalTrials.gov