A Phase 2 interventional study of XT-150 and Placebo in Facet Joint Pain, Back Pain and Inflammation, sponsored by Xalud Therapeutics, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Xalud Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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).
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
This study's enrollment of 75 is close to the median of 70 across 593 interventional studies indexed under Back Pain.
Browse Back Pain studies →Xalud Therapeutics, Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are required to meet ALL of the following inclusion criteria:
Exclusion Criteria:
Participants must NOT meet any of the following exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Biological: XT-150
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Biological: Placebo
XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
Phosphate-buffered saline for injection
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 270
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.
Time frame: Day 270
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.
Time frame: 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.
Time frame: Day 270
| Milestone | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| Started | 25 | 25 | 25 |
| Completed | 18 | 22 | 24 |
| Not completed | 7 | 3 | 1 |
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.
| Participants | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| Any TEAEs — Yes | 11 | 12 | 14 |
| Any TEAEs — No | 14 | 13 | 11 |
| Related TEAEs — Yes | 1 | 1 | 3 |
| Related TEAEs — No | 24 | 24 | 22 |
| Serious TEAEs — Yes | 1 | 1 | 0 |
| Serious TEAEs — No | 24 | 24 | 25 |
| Related Serious TEAEs — Yes | 0 | 0 | 0 |
| Related Serious TEAEs — No | 25 | 25 | 25 |
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.
| Participants | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| Day 0 — Normal | 22 | 24 | 23 |
| Day 0 — Abnormal - Not Clinically Significant | 3 | 1 | 2 |
| Day 0 — Abnormal Clinically Significant | 0 | 0 | 0 |
| Day 0 — Not Analyzed (Missing Data) | 0 | 0 | 0 |
| Day 270 — Normal | 15 | 19 | 20 |
| Day 270 — Abnormal - Not Clinically Significant | 0 | 1 | 0 |
| Day 270 — Abnormal Clinically Significant | 0 | 0 | 0 |
| Day 270 — Not Analyzed (Missing Data) | 10 | 5 | 5 |
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.
| score on a scale | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS) | -38.12 ± 6.432 | -34.37 ± 5.717 | -42.32 ± 5.811 |
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.
| score on a scale | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| Change From Baseline in Oswestry Disability Index (ODI) Scores | -14.4 ± 3.43 | -3.11 ± 3.104 | -8.25 ± 3.17 |
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.
| score on a scale | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| Change From Baseline in Patient Global Assessment (PGA) Scores | -0.6 ± 1.55 | -0.7 ± 1.18 | -0.9 ± 0.97 |
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.
| days | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| Days vigorous physical activity during last 7 days | 0.7 ± 2.43 | -0.6 ± 1.64 | -0.3 ± 1.06 |
| Days moderate physical activity during last 7 days | 1.5 ± 3.44 | -0.6 ± 3.45 | 0.2 ± 3.08 |
| Days walking at least 10 minutes during last 7 days | 0.9 ± 2.64 | -0.8 ± 3.07 | -0.5 ± 3.27 |
Collected over 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.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.15mg XT-150 | 0/25 (0%) | 1/25 (4%) | 11/25 (44%) |
| 0.45mg XT-150 | 0/25 (0%) | 1/25 (4%) | 12/25 (48%) |
| Placebo | 0/25 (0%) | 0/25 (0%) | 14/25 (56%) |
| Event | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| Aortic DissectionVascular disorders | 1/25 | 0/25 | 0/25 |
| Large B-cell lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/25 | 1/25 | 0/25 |
| Event | 0.15mg XT-150 | 0.45mg XT-150 | Placebo |
|---|---|---|---|
| COVID-19Infections and infestations | 5/25 | 1/25 | 4/25 |
| Back PainMusculoskeletal and connective tissue disorders | 5/25 | 5/25 | 3/25 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/25 | 3/25 | 2/25 |
| InfluenzaInfections and infestations | 2/25 | 0/25 | 0/25 |
| NasopharyngitisInfections and infestations | 2/25 | 0/25 | 0/25 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/25 | 0/25 | 2/25 |
| Muscle strainInjury, poisoning and procedural complications | 0/25 | 1/25 | 1/25 |
| Traumatic haematomaInjury, poisoning and procedural complications | 0/25 | 1/25 | 1/25 |
| LethargyNervous system disorders | 0/25 | 1/25 | 1/25 |
| Age, Continuous(years) | 0.15mg XT-150 | 0.45mg XT-150 | Placebo | Total |
|---|---|---|---|---|
| Mean | 59.5 ± 9.71 | 58.0 ± 13.11 | 63.6 ± 13.74 | 60.3 ± 12.37 |
| Sex: Female, Male(Participants) | 0.15mg XT-150 | 0.45mg XT-150 | Placebo | Total |
|---|---|---|---|---|
| Female | 13 | 8 | 13 | 34 |
| Male | 12 | 17 | 12 | 41 |
| Ethnicity (NIH/OMB)(Participants) | 0.15mg XT-150 | 0.45mg XT-150 | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 | 6 |
| Not Hispanic or Latino | 25 | 22 | 22 | 69 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 0.15mg XT-150 | 0.45mg XT-150 | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 3 | 11 |
| White | 19 | 21 | 19 | 59 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | 0.15mg XT-150 | 0.45mg XT-150 | Placebo | Total |
|---|---|---|---|---|
| United States | 25 | 25 | 25 | 75 |
| Body Mass Index (BMI)(kg/m2) | 0.15mg XT-150 | 0.45mg XT-150 | Placebo | Total |
|---|---|---|---|---|
| Mean | 31.0 ± 6.23 | 31.0 ± 6.77 | 27.7 ± 6.44 | 29.9 ± 6.59 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2022 to primary completion in Sep 2023, 18 months.
Results were first posted in Jan 2025, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: XT-150
Xalud Therapeutics, Inc.