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 2 safety and efficacy study of XT-150 in adult participants experiencing moderate to severe pain due to osteoarthritis of the knee.
In this Phase 2 study, Baseline (Day 0) confirmation of study eligibility will be completed the day before or day of study drug administration.
Study drug will be administered by intra-articular (IA) injection into the joint space of the index knee (knee selected for treatment).
Up to 270 participants will be randomly enrolled into 1 of 6 treatment sequences (45 participants/ group). Treatment Groups:
The study will be conducted in 2 stages, A and B. Participants will be randomized at Day 0 to a treatment regimen, one treatment assignment for Stage A and one treatment assignment for Stage B:
Stage A (Up to Day 180): Participants will receive placebo, 0.15 mg/mL XT-150 or 0.45 mg/mL XT-150 to the index knee at Day 0.
Stage B (Day 180 to Day 360): Participants will have the option to receive a pre-randomized dose (XT-150 0.15 mg/mL or 0.45 mg/mL) to the index knee anytime between Day 180 and Day 330.
Final assessments will be 12 months after the first IA dose.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Experimental | Low dose active in Stage A and Stage B |
|
| Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Experimental | Low dose active in Stage A, high dose active in Stage B |
|
| Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Experimental | High dose active in Stage A, low dose active in Stage B |
|
| Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Experimental | High dose active in Stage A and Stage B |
|
| Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Placebo Comparator | Inactive comparator in Stage A, low dose active in Stage B |
|
| Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XT-150 | Biological | plasmid DNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage A: Number of Participants Achieving 30% Improvement From Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) Pain Score | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | Day 180 |
| Stage A: Change From Baseline in WOMAC Pain Score at Day 180 | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | Day 180 |
| Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination. This analysis reports any AEs/SAEs that occurred prior to the second dose. | Prior to second dose (Up to Day 180-Day 330) |
| Stage B: Number of Participants With AEs and SAEs | Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination. This analysis reports any AEs/SAEs that occurred after the second dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Stage B: Change From Baseline in WOMAC Pain Score at Day 360 | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eStudySite | La Mesa | California | 91942 | United States | ||
| Neurovations (Napa Pain Institute) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40826764 | Derived | Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
289 participants signed a consent form, but 3 withdrew during the screening period. 286 participants were dosed and that is the number reflected in this section. The data listed here is based on the Safety Population and actual treatment received, not the ITT population. One participant received 0.15mg due to a site error, although they were originally randomized to 0.45mg in Stage A.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Low dose active in Stage A and Stage B XT-150: plasmid DNA |
| FG001 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Low dose active in Stage A, high dose active in Stage B XT-150: plasmid DNA |
| FG002 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | High dose active in Stage A, low dose active in Stage B XT-150: plasmid DNA |
| FG003 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | High dose active in Stage A and Stage B XT-150: plasmid DNA |
| FG004 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Inactive comparator in Stage A, low dose active in Stage B XT-150: plasmid DNA Placebo: Placebo is a sterile phosphate-buffered saline |
| FG005 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Inactive comparator in Stage A, high dose active in Stage B XT-150: plasmid DNA Placebo: Placebo is a sterile phosphate-buffered saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants listed here is based on the Safety Population and actual treatment received, not the ITT population. One participant received 0.15mg due to a site error, although they were originally randomized to 0.45mg in Stage A.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Low dose active in Stage A and Stage B XT-150: plasmid DNA |
| BG001 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL 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 | Stage A: Number of Participants Achieving 30% Improvement From Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) Pain Score | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. One (1) participant was randomized to 0.45 mg/ml XT-150 but inadvertently received 0.15 mg/ml XT-150 due to site error, explaining the difference between number analyzed in XT-150 groups compared to the overall participant flow. | Posted | Count of Participants | Participants | Day 180 |
Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) 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 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Low dose active in Stage A and Stage B XT-150: plasmid DNA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | 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 | Mar 25, 2020 | Nov 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2021 | Nov 20, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Inactive comparator in Stage A, high dose active in Stage B |
|
| Placebo | Drug | Placebo is a sterile phosphate-buffered saline |
|
| Post Second Dose (Day 180-Day 330 through Day 360) |
| Day 360 |
| Stage B: Change From Baseline in WOMAC Function Score | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score will be obtained from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The function dimension category asks about the degree of difficulty in doing 17 activities. The score ranges from 0 (normal function) to 170 (severely limited function); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | At Day 360 |
| Stage A: Change From Baseline in Brief Pain Inventory (BPI) of Interference Score | The Brief Pain Inventory (BPI) is a self-administered questionnaire for participants to rate the degree to which their pain interferes with common dimensions of feeling and function. The 7 pain interference items will be rated on 0-10 scale. Total interference score ranges from 0 (does not interfere) to 10 (completely interferes); higher score indicates worse outcomes. | Day 180 |
| Stage A: Change From Baseline in Patients Overall Assessment (POA) | The Patient Overall Assessment (POA) is a self-administered questionnaire that records participants' responses to the question "Considering all the ways the OA in your knee affects you, how are you doing today?" on a scale of 1 to 5; 1 being very good (asymptomatic and no limitation of normal activities) to 5, very poor (very severe, intolerable symptoms and inability to carry out normal activities). Higher score indicates worse symptoms. | Day 180 |
| Stage A and B: Number of Participants With Presence of Anti-interleukin (IL)-10 Antibody | Presence of Immunoglobulin M (IgM) or Immunoglobulin G (IgG) antibodies against human IL-10 in serum was assessed at Baseline/Day 0 and then post-initial dose on Days 7, 30, 60, 180, and 360. | Up to Day 360 |
| Napa |
| California |
| 94558 |
| United States |
| Source Healthcare | Santa Monica | California | 90403 | United States |
| Carolinas Clinical Research Institute | Winston-Salem | North Carolina | 27103 | United States |
| University of Adelaide in collaboration with CMAX Clinical Research Pty Ltd | Adelaide | South Australia | 5005 | Australia |
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
Low dose active in Stage A, high dose active in Stage B
XT-150: plasmid DNA
| BG002 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | High dose active in Stage A, low dose active in Stage B XT-150: plasmid DNA |
| BG003 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | High dose active in Stage A and Stage B XT-150: plasmid DNA |
| BG004 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Inactive comparator in Stage A, low dose active in Stage B XT-150: plasmid DNA Placebo: Placebo is a sterile phosphate-buffered saline |
| BG005 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Inactive comparator in Stage A, high dose active in Stage B XT-150: plasmid DNA Placebo: Placebo is a sterile phosphate-buffered saline |
| BG006 | 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 |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Stage A: 0.15 mg/ml XT-150 | Low dose active in Stage A |
| OG001 | Stage A: 0.45 mg/ml XT-150 | High dose active in Stage A |
| OG002 | Stage A: Placebo | Inactive comparator in Stage A |
|
|
|
| Primary | Stage A: Change From Baseline in WOMAC Pain Score at Day 180 | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. One (1) participant was randomized to 0.45 mg/ml XT-150 but inadvertently received 0.15 mg/ml XT-150 due to site error, explaining the difference between number analyzed in XT-150 groups compared to the overall participant flow. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 180 |
|
|
|
|
| Primary | Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination. This analysis reports any AEs/SAEs that occurred prior to the second dose. | The Safety Population will comprise all participants who receive any amount of study drug, analyzed according to treatment actually received. | Posted | Count of Participants | Participants | Prior to second dose (Up to Day 180-Day 330) |
|
|
|
| Primary | Stage B: Number of Participants With AEs and SAEs | Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination. This analysis reports any AEs/SAEs that occurred after the second dose. | The Safety Population will comprise all participants who receive any amount of study drug, analyzed according to treatment actually received. | Posted | Count of Participants | Participants | Post Second Dose (Day 180-Day 330 through Day 360) |
|
|
|
| Secondary | Stage B: Change From Baseline in WOMAC Pain Score at Day 360 | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 360 |
|
|
|
| Secondary | Stage B: Change From Baseline in WOMAC Function Score | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score will be obtained from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The function dimension category asks about the degree of difficulty in doing 17 activities. The score ranges from 0 (normal function) to 170 (severely limited function); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. | Posted | Least Squares Mean | Standard Error | score on a scale | At Day 360 |
|
|
|
| Secondary | Stage A: Change From Baseline in Brief Pain Inventory (BPI) of Interference Score | The Brief Pain Inventory (BPI) is a self-administered questionnaire for participants to rate the degree to which their pain interferes with common dimensions of feeling and function. The 7 pain interference items will be rated on 0-10 scale. Total interference score ranges from 0 (does not interfere) to 10 (completely interferes); higher score indicates worse outcomes. | The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. One (1) participant was randomized to 0.45 mg/ml XT-150 but inadvertently received 0.15 mg/ml XT-150 due to site error, explaining the difference between number analyzed in XT-150 groups compared to the overall participant flow. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 180 |
|
|
|
|
| Secondary | Stage A: Change From Baseline in Patients Overall Assessment (POA) | The Patient Overall Assessment (POA) is a self-administered questionnaire that records participants' responses to the question "Considering all the ways the OA in your knee affects you, how are you doing today?" on a scale of 1 to 5; 1 being very good (asymptomatic and no limitation of normal activities) to 5, very poor (very severe, intolerable symptoms and inability to carry out normal activities). Higher score indicates worse symptoms. | The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. One (1) participant was randomized to 0.45 mg/ml XT-150 but inadvertently received 0.15 mg/ml XT-150 due to site error, explaining the difference between number analyzed in XT-150 groups compared to the overall participant flow. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 180 |
|
|
|
|
| Secondary | Stage A and B: Number of Participants With Presence of Anti-interleukin (IL)-10 Antibody | Presence of Immunoglobulin M (IgM) or Immunoglobulin G (IgG) antibodies against human IL-10 in serum was assessed at Baseline/Day 0 and then post-initial dose on Days 7, 30, 60, 180, and 360. | The Safety Population will comprise all participants who receive any amount of study drug, analyzed according to treatment actually received. | Posted | Count of Participants | Participants | Up to Day 360 |
|
|
|
| Post-Hoc | Post-Hoc WOMAC Pain Score Change From Baseline - 2-dose 0.45mg XT-150 vs. Single-dose 0.45mg XT-150 (mITT) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. The data reported in this outcome measure is a head-to-head comparison of two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml and only includes these 2 treatment sequences whereas outcome measure #12 reports the least squared mean based on data for all 6 treatment sequences. | The Modified Intent-to-Treat population consists of the ITT population who received at least one treatment injection with a baseline WOMAC Pain score of 9-20 (>8). This is the target population of interest who may benefit most from the treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 360 |
|
|
|
|
| Post-Hoc | Post-Hoc WOMAC Function Score Change From Baseline - 2-dose 0.45mg XT-150 vs. Single-dose 0.45mg XT-150 (mITT) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score will be obtained from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The function dimension category asks about the degree of difficulty in doing 17 activities. The score ranges from 0 (normal function) to 170 (severely limited function); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. The data reported in this outcome measure is a head-to-head comparison of two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml and only includes these 2 treatment sequences whereas outcome measure #13 reports the least squared mean based on data for all 6 treatment sequences. | The Modified Intent-to-Treat population consists of the ITT population who received at least one treatment injection with a baseline WOMAC Pain score of 9-20 (>8). This is the target population of interest who may benefit most from the treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 360 |
|
|
|
|
| Post-Hoc | Post-Hoc WOMAC Pain Score Change From Baseline - All Dose Regimens (mITT) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | The Modified Intent-to-Treat population consists of the ITT population who received at least one treatment injection with a baseline WOMAC Pain score of 9-20 (>8). This is the target population of interest who may benefit most from the treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 360 |
|
|
|
| Post-Hoc | Post-Hoc WOMAC Function Score Change From Baseline - All Dose Regimens (mITT) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score will be obtained from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The function dimension category asks about the degree of difficulty in doing 17 activities. The score ranges from 0 (normal function) to 170 (severely limited function); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. | The Modified Intent-to-Treat population consists of the ITT population who received at least one treatment injection with a baseline WOMAC Pain score of 9-20 (>8). This is the target population of interest who may benefit most from the treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Day 360 |
|
|
|
| 1 |
| 49 |
| 3 |
| 49 |
| 15 |
| 49 |
| EG001 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Low dose active in Stage A, high dose active in Stage B XT-150: plasmid DNA | 0 | 47 | 2 | 47 | 16 | 47 |
| EG002 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | High dose active in Stage A, low dose active in Stage B XT-150: plasmid DNA | 0 | 47 | 3 | 47 | 18 | 47 |
| EG003 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | High dose active in Stage A and Stage B XT-150: plasmid DNA | 0 | 47 | 2 | 47 | 24 | 47 |
| EG004 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Inactive comparator in Stage A, low dose active in Stage B XT-150: plasmid DNA Placebo: Placebo is a sterile phosphate-buffered saline | 0 | 48 | 4 | 48 | 10 | 48 |
| EG005 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Inactive comparator in Stage A, high dose active in Stage B XT-150: plasmid DNA Placebo: Placebo is a sterile phosphate-buffered saline | 0 | 48 | 3 | 48 | 23 | 48 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Gastrointestinal procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Infections and infestations | MedDRA | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | 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.
| D012216 |
| Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 0.629 |
| Mean Difference (Final Values) |
| 0.26 |
| Standard Error of the Mean |
| 0.535 |
| 2-Sided |
| 95 |
| -0.79 |
| 1.31 |
| Superiority |
| Related TEAEs |
|
| Serious TEAEs |
|
| Related Serious TEAEs |
|
| No |
|
| Related TEAE |
|
| Serious TEAE |
|
| Related Serious TEAE |
|
| Mean Difference (Final Values) |
| 0.35 |
| 2-Sided |
| 95 |
| -0.29 |
| 1.00 |
| Superiority |
| 0.968 |
| Mean Difference (Final Values) |
| 0.01 |
| Standard Error of the Mean |
| 0.140 |
| 2-Sided |
| 95 |
| -0.27 |
| 0.28 |
| Superiority |
| No Anti-IL-10 Antibodies Detected |
|