Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XT-150 | Biological | XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Oswestry Disability Index (ODI) Scores | 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. | Day 270 |
Not provided
Inclusion Criteria:
Participants are required to meet ALL of the following inclusion criteria:
Exclusion Criteria:
Participants must NOT meet any of the following exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Morgan Stokes | Xalud Therapeutics | Study Director |
| Howard Rutman, MD | Xalud Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurovations | Napa | California | 94558 | United States | ||
| Source HealthCare |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.15mg 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. XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution. |
| FG001 | 0.45mg 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. XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution. |
| FG002 | Placebo | Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. Placebo: Phosphate-buffered saline for injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.15mg 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. XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution. |
| BG001 | 0.45mg XT-150 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population | Posted | Count of Participants | Participants | 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 occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.15mg 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. XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic Dissection | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Inquiries | Xalud Therapeutics, Inc. | 212-301-6673 | medical.information@xaludthera.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2022 | Dec 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2023 | Dec 2, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Placebo controlled, double blind
| Placebo | Biological | Phosphate-buffered saline for injection |
|
| Change From Baseline in Patient Global Assessment (PGA) Scores |
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. |
| Up to Day 270 |
| Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | 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. | Day 270 |
| Santa Monica |
| California |
| 90403 |
| United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution. |
| BG002 | Placebo | Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. Placebo: Phosphate-buffered saline for injection |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
| OG002 | Placebo | Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. Placebo: Phosphate-buffered saline for injection |
|
|
| Primary | 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. | Safety population | Posted | Count of Participants | Participants | Up to Day 270 |
|
|
|
| Primary | 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. | Intent to Treat (ITT) population: All participants who were randomized who received the treatment injection analyzed according to randomized treatment. This was a phase 2a safety study that was not statistically powered for efficacy assessments. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 270 |
|
|
|
|
| Secondary | Change From Baseline in Oswestry Disability Index (ODI) Scores | 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. | Intent to Treat (ITT) population: All participants who were randomized who received the treatment injection analyzed according to randomized treatment. This was a phase 2a safety study that was not statistically powered for efficacy assessments. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 270 |
|
|
|
|
| Secondary | Change From Baseline in Patient Global Assessment (PGA) Scores | 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. | Intent to Treat (ITT) population: All participants who were randomized who received the treatment injection analyzed according to randomized treatment. This was a phase 2a safety study that was not statistically powered for efficacy assessments. | Posted | Mean | Standard Deviation | score on a scale | Up to Day 270 |
|
|
|
| Secondary | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | 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. | Intent to Treat (ITT) population: All participants who were randomized who received the treatment injection analyzed according to randomized treatment. This was a phase 2a safety study that was not statistically powered for efficacy assessments. | Posted | Mean | Standard Deviation | days | Day 270 |
|
|
|
| 0 |
| 25 |
| 1 |
| 25 |
| 11 |
| 25 |
| EG001 | 0.45mg 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. XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution. | 0 | 25 | 1 | 25 | 12 | 25 |
| EG002 | Placebo | Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90. Placebo: Phosphate-buffered saline for injection | 0 | 25 | 0 | 25 | 14 | 25 |
| Large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lethargy | Nervous system disorders | Systematic Assessment |
|
PI is bound to terms and conditions of a Sponsored Clinical Trial Agreement which has strict confidentiality obligations running to Sponsor and broad provisions restricting PI's rights to publish or present any data or Study Results without Sponsor's express review consent and review.
| D010335 | Pathologic Processes |
| Abnormal Clinically Significant |
|
| Not Analyzed (Missing Data) |
|
| Day 270 |
|
This was a phase 2a safety study that was not statistically powered for efficacy assessments.
| Mixed Models Analysis |
| 0.99 |
| Mean Difference (Final Values) |
| 7.96 |
| Standard Error of the Mean |
| 8.142 |
| 2-Sided |
| 95 |
| -17.12 |
| 33.03 |
| Superiority |
This was a phase 2a safety study that was not statistically powered for efficacy assessments.
| Mixed Models Analysis |
| 0.2511 |
| Mean Difference (Final Values) |
| 5.14 |
| Standard Error of the Mean |
| 4.434 |
| 2-Sided |
| 95 |
| -3.73 |
| 14.00 |
| Superiority |
|
| Days walking at least 10 minutes during last 7 days |
|