Back Pain, Facet Joint Pain, Inflammation
Conditions
Keywords
FJOA, Facetogenic Pain, Intra-articular Injection
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)
Interventions
BIOLOGICALXT-150
XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
BIOLOGICALPlacebo
Phosphate-buffered saline for injection
Sponsors
Xalud Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo controlled, double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| 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 | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | 0.15mg XT-150 | 0.45mg XT-150 | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 9.71 | 58.0 years STANDARD_DEVIATION 13.11 | 63.6 years STANDARD_DEVIATION 13.74 | 60.3 years STANDARD_DEVIATION 12.37 |
| Body Mass Index (BMI) | 31.0 kg/m2 STANDARD_DEVIATION 6.23 | 31.0 kg/m2 STANDARD_DEVIATION 6.77 | 27.7 kg/m2 STANDARD_DEVIATION 6.44 | 29.9 kg/m2 STANDARD_DEVIATION 6.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 22 Participants | 22 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 21 Participants | 19 Participants | 59 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 13 Participants | 8 Participants | 13 Participants | 34 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 12 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 11 / 25 | 12 / 25 | 14 / 25 |
| serious Total, serious adverse events | 1 / 25 | 1 / 25 | 0 / 25 |
Outcome results
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.
Time frame: Day 270
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.15mg XT-150 | Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS) | -38.12 score on a scale | Standard Error 6.432 |
| 0.45mg XT-150 | Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS) | -34.37 score on a scale | Standard Error 5.717 |
| Placebo | Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS) | -42.32 score on a scale | Standard Error 5.811 |
Comparison: This was a phase 2a safety study that was not statistically powered for efficacy assessments.p-value: 195% CI: [-22.57, 30.97]Mixed Models Analysis
Comparison: This was a phase 2a safety study that was not statistically powered for efficacy assessments.p-value: 0.9995% CI: [-17.12, 33.03]Mixed Models Analysis
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.
Time frame: Up to Day 270
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 0.15mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Normal | 22 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Abnormal - Not Clinically Significant | 3 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Abnormal Clinically Significant | 0 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Not Analyzed (Missing Data) | 0 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Normal | 15 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Abnormal - Not Clinically Significant | 0 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Abnormal Clinically Significant | 0 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Not Analyzed (Missing Data) | 10 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Abnormal Clinically Significant | 0 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Abnormal Clinically Significant | 0 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Not Analyzed (Missing Data) | 0 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Normal | 19 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Abnormal - Not Clinically Significant | 1 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Normal | 24 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Abnormal - Not Clinically Significant | 1 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Not Analyzed (Missing Data) | 5 Participants |
| Placebo | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Abnormal Clinically Significant | 0 Participants |
| Placebo | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Abnormal - Not Clinically Significant | 2 Participants |
| Placebo | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Normal | 23 Participants |
| Placebo | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 0 | Not Analyzed (Missing Data) | 0 Participants |
| Placebo | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Abnormal Clinically Significant | 0 Participants |
| Placebo | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Abnormal - Not Clinically Significant | 0 Participants |
| Placebo | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Normal | 20 Participants |
| Placebo | Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs | Day 270 | Not Analyzed (Missing Data) | 5 Participants |
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.
Time frame: Up to Day 270
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 0.15mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related Serious TEAEs | No | 25 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Any TEAEs | Yes | 11 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related Serious TEAEs | Yes | 0 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related TEAEs | Yes | 1 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Any TEAEs | No | 14 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related TEAEs | No | 24 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Serious TEAEs | Yes | 1 Participants |
| 0.15mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Serious TEAEs | No | 24 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Serious TEAEs | Yes | 1 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Serious TEAEs | No | 24 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Any TEAEs | No | 13 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related TEAEs | Yes | 1 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related Serious TEAEs | Yes | 0 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Any TEAEs | Yes | 12 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related Serious TEAEs | No | 25 Participants |
| 0.45mg XT-150 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related TEAEs | No | 24 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related Serious TEAEs | No | 25 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related TEAEs | Yes | 3 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Any TEAEs | Yes | 14 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related TEAEs | No | 22 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Serious TEAEs | Yes | 0 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Serious TEAEs | No | 25 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Related Serious TEAEs | Yes | 0 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Any TEAEs | No | 11 Participants |
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.
Time frame: Day 270
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.15mg XT-150 | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days moderate physical activity during last 7 days | 1.5 days | Standard Deviation 3.44 |
| 0.15mg XT-150 | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days vigorous physical activity during last 7 days | 0.7 days | Standard Deviation 2.43 |
| 0.15mg XT-150 | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days walking at least 10 minutes during last 7 days | 0.9 days | Standard Deviation 2.64 |
| 0.45mg XT-150 | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days moderate physical activity during last 7 days | -0.6 days | Standard Deviation 3.45 |
| 0.45mg XT-150 | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days vigorous physical activity during last 7 days | -0.6 days | Standard Deviation 1.64 |
| 0.45mg XT-150 | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days walking at least 10 minutes during last 7 days | -0.8 days | Standard Deviation 3.07 |
| Placebo | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days vigorous physical activity during last 7 days | -0.3 days | Standard Deviation 1.06 |
| Placebo | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days walking at least 10 minutes during last 7 days | -0.5 days | Standard Deviation 3.27 |
| Placebo | Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores | Days moderate physical activity during last 7 days | 0.2 days | Standard Deviation 3.08 |
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.
Time frame: Day 270
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.15mg XT-150 | Change From Baseline in Oswestry Disability Index (ODI) Scores | -14.4 score on a scale | Standard Error 3.43 |
| 0.45mg XT-150 | Change From Baseline in Oswestry Disability Index (ODI) Scores | -3.11 score on a scale | Standard Error 3.104 |
| Placebo | Change From Baseline in Oswestry Disability Index (ODI) Scores | -8.25 score on a scale | Standard Error 3.17 |
Comparison: This was a phase 2a safety study that was not statistically powered for efficacy assessments.p-value: 0.193395% CI: [-15.49, 3.19]Mixed Models Analysis
Comparison: This was a phase 2a safety study that was not statistically powered for efficacy assessments.p-value: 0.251195% CI: [-3.73, 14]Mixed Models Analysis
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.
Time frame: Up to Day 270
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.15mg XT-150 | Change From Baseline in Patient Global Assessment (PGA) Scores | -0.6 score on a scale | Standard Deviation 1.55 |
| 0.45mg XT-150 | Change From Baseline in Patient Global Assessment (PGA) Scores | -0.7 score on a scale | Standard Deviation 1.18 |
| Placebo | Change From Baseline in Patient Global Assessment (PGA) Scores | -0.9 score on a scale | Standard Deviation 0.97 |