A Phase 2 interventional study of XT-150 and Placebo in Osteoarthritis, Knee, sponsored by Xalud Therapeutics, Inc.. Completed at 6 sites in 2 countries. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Xalud Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 289 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee 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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Low dose active in Stage A and Stage B
Biological: XT-150
Low dose active in Stage A, high dose active in Stage B
Biological: XT-150
High dose active in Stage A, low dose active in Stage B
Biological: XT-150
High dose active in Stage A and Stage B
Biological: XT-150
Inactive comparator in Stage A, low dose active in Stage B
Biological: XT-150 · Drug: Placebo
Inactive comparator in Stage A, high dose active in Stage B
Biological: XT-150 · Drug: Placebo
plasmid DNA
Placebo is a sterile phosphate-buffered saline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post Second Dose (Day 180-Day 330 through Day 360)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 360
| Milestone | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| Started | 49 | 47 | 47 | 47 | 48 | 48 |
| Completed | 39 | 42 | 38 | 39 | 42 | 43 |
| Not completed | 10 | 5 | 9 | 8 | 6 | 5 |
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.
| Participants | Stage A: 0.15 mg/ml XT-150 | Stage A: 0.45 mg/ml XT-150 | Stage A: Placebo |
|---|---|---|---|
| Responder | 26 | 28 | 38 |
| Non-responder | 53 | 56 | 51 |
| Not Analyzed | 16 | 11 | 7 |
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.
| score on a scale | Stage A: 0.15 mg/ml XT-150 | Stage A: 0.45 mg/ml XT-150 | Stage A: Placebo |
|---|---|---|---|
| Stage A: Change From Baseline in WOMAC Pain Score at Day 180 | -1.77 ± 0.386 | -1.95 ± 0.380 | -2.21 ± 0.374 |
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.
| Participants | Stage A: 0.15 mg/ml XT-150 | Stage A: 0.45 mg/ml XT-150 | Stage A: Placebo |
|---|---|---|---|
| Any TEAEs — Yes | 30 | 53 | 38 |
| Any TEAEs — No | 66 | 41 | 58 |
| Related TEAEs — Yes | 4 | 0 | 4 |
| Related TEAEs — No | 92 | 94 | 92 |
| Serious TEAEs — Yes | 2 | 3 | 6 |
| Serious TEAEs — No | 94 | 91 | 90 |
| Related Serious TEAEs — Yes | 0 | 0 | 0 |
| Related Serious TEAEs — No | 96 | 94 | 96 |
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.
| Participants | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| Any TEAE — Yes | 12 | 14 | 18 | 16 | 9 | 18 |
| Any TEAE — No | 27 | 27 | 19 | 25 | 34 | 25 |
| Related TEAE — Yes | 0 | 0 | 0 | 1 | 0 | 1 |
| Related TEAE — No | 39 | 41 | 37 | 40 | 43 | 42 |
| Serious TEAE — Yes | 2 | 1 | 1 | 1 | 0 | 1 |
| Serious TEAE — No | 37 | 40 | 36 | 40 | 43 | 42 |
| Related Serious TEAE — Yes | 0 | 0 | 0 | 0 | 0 | 0 |
| Related Serious TEAE — No | 39 | 41 | 37 | 41 | 43 | 43 |
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.
| score on a scale | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| Stage B: Change From Baseline in WOMAC Pain Score at Day 360 | -3.4 ± 0.666 | -3.26 ± 0.662 | -3.44 ± 0.682 | -3.87 ± 0.643 | -2.9 ± 0.659 | -2.9 ± 0.639 |
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.
| score on a scale | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| Stage B: Change From Baseline in WOMAC Function Score | -11.23 ± 2.236 | -11.79 ± 2.292 | -12.8 ± 2.330 | -13.63 ± 2.218 | -9.44 ± 2.292 | -8.66 ± 2.164 |
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.
| score on a scale | Stage A: 0.15 mg/ml XT-150 | Stage A: 0.45 mg/ml XT-150 | Stage A: Placebo |
|---|---|---|---|
| Stage A: Change From Baseline in Brief Pain Inventory (BPI) of Interference Score | -0.96 ± 0.263 | -1.10 ± 0.253 | -1.46 ± 0.258 |
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.
| score on a scale | Stage A: 0.15 mg/ml XT-150 | Stage A: 0.45 mg/ml XT-150 | Stage A: Placebo |
|---|---|---|---|
| Stage A: Change From Baseline in Patients Overall Assessment (POA) | -0.19 ± 0.102 | -0.32 ± 0.100 | -0.33 ± 0.098 |
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.
| Participants | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| Anti-IL-10 Antibodies Detected | 0 | 0 | 0 | 0 | 0 | 0 |
| No Anti-IL-10 Antibodies Detected | 49 | 47 | 47 | 47 | 48 | 48 |
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.
| score on a scale | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|
| Post-Hoc WOMAC Pain Score Change From Baseline - 2-dose 0.45mg XT-150 vs. Single-dose 0.45mg XT-150 (mITT) | -5.02 ± 0.815 | -2.19 ± 0.911 |
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.
| score on a scale | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|
| Post-Hoc WOMAC Function Score Change From Baseline - 2-dose 0.45mg XT-150 vs. Single-dose 0.45mg XT-150 (mITT) | -15.42 ± 2.887 | -5.82 ± 3.201 |
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.
| score on a scale | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| Post-Hoc WOMAC Pain Score Change From Baseline - All Dose Regimens (mITT) | -3.76 ± 0.835 | -3.53 ± 0.800 | -4.07 ± 0.797 | -4.93 ± 0.789 | -3.03 ± 0.805 | -2.42 ± 0.852 |
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.
| score on a scale | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| Post-Hoc WOMAC Function Score Change From Baseline - All Dose Regimens (mITT) | -12.73 ± 2.810 | -12.42 ± 2.767 | -13.95 ± 2.695 | -15.28 ± 2.731 | -9.33 ± 2.848 | -7.03 ± 2.904 |
Collected over 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.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | 1/49 (2%) | 3/49 (6.1%) | 15/49 (30.6%) |
| Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | 0/47 (0%) | 2/47 (4.3%) | 16/47 (34%) |
| Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | 0/47 (0%) | 3/47 (6.4%) | 18/47 (38.3%) |
| Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | 0/47 (0%) | 2/47 (4.3%) | 24/47 (51.1%) |
| Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | 0/48 (0%) | 4/48 (8.3%) | 10/48 (20.8%) |
| Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | 0/48 (0%) | 3/48 (6.3%) | 23/48 (47.9%) |
| Event | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/49 | 1/47 | 0/47 | 0/47 | 0/48 | 0/48 |
| Cartilage injuryInjury, poisoning and procedural complications | 0/49 | 0/47 | 1/47 | 0/47 | 0/48 | 0/48 |
| Femoral neck fractureInjury, poisoning and procedural complications | 0/49 | 1/47 | 0/47 | 0/47 | 0/48 | 0/48 |
| Gastrointestinal procedural complicationInjury, poisoning and procedural complications | 0/49 | 0/47 | 0/47 | 1/47 | 0/48 | 0/48 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/49 | 0/47 | 1/47 | 1/47 | 0/48 | 1/48 |
| Myocardial infarctionCardiac disorders | 1/49 | 0/47 | 1/47 | 0/47 | 0/48 | 0/48 |
| Anal squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/49 | 0/47 | 0/47 | 0/47 | 1/48 | 0/48 |
| Gastrointestinal stromal tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/49 | 0/47 | 0/47 | 0/47 | 0/48 | 1/48 |
| Lung adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/49 | 0/47 | 0/47 | 0/47 | 1/48 | 0/48 |
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/49 | 0/47 | 0/47 | 0/47 | 1/48 | 0/48 |
| Event | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 |
|---|---|---|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/49 | 7/47 | 9/47 | 8/47 | 3/48 | 7/48 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/49 | 2/47 | 2/47 | 3/47 | 2/48 | 7/48 |
| COVID-19Infections and infestations | 2/49 | 3/47 | 0/47 | 5/47 | 0/48 | 2/48 |
| ContusionInjury, poisoning and procedural complications | 2/49 | 1/47 | 1/47 | 4/47 | 0/48 | 2/48 |
| Ligament sprainInjury, poisoning and procedural complications | 1/49 | 1/47 | 1/47 | 4/47 | 0/48 | 3/48 |
| Back painMusculoskeletal and connective tissue disorders | 3/49 | 0/47 | 0/47 | 3/47 | 2/48 | 1/48 |
| Joint SwellingMusculoskeletal and connective tissue disorders | 2/49 | 1/47 | 2/47 | 3/47 | 0/48 | 1/48 |
| Urinary tract infectionInfections and infestations | 0/49 | 1/47 | 3/47 | 1/47 | 0/48 | 2/48 |
| HypertensionVascular disorders | 0/49 | 1/47 | 1/47 | 3/47 | 0/48 | 1/48 |
| Procedural painInfections and infestations | 1/49 | 2/47 | 2/47 | 0/47 | 2/48 | 3/48 |
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.
| Age, Continuous(years) | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 62.1 ± 8.15 | 62.0 ± 6.68 | 64.9 ± 7.09 | 62.6 ± 7.82 | 62.9 ± 7.35 | 65.3 ± 9.52 | 63.3 ± 7.79 |
| Sex: Female, Male(Participants) | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Total |
|---|---|---|---|---|---|---|---|
| Female | 20 | 20 | 22 | 33 | 27 | 33 | 155 |
| Male | 29 | 27 | 25 | 14 | 21 | 15 | 131 |
| Ethnicity (NIH/OMB)(Participants) | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 7 | 4 | 0 | 0 | 1 | 2 | 14 |
| Not Hispanic or Latino | 42 | 43 | 47 | 47 | 47 | 46 | 272 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Asian | 0 | 0 | 1 | 2 | 0 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 10 | 6 | 5 | 5 | 11 | 4 | 41 |
| White | 35 | 41 | 39 | 38 | 31 | 39 | 223 |
| More than one race | 3 | 0 | 2 | 2 | 3 | 2 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 2 | 0 | 2 |
| Body Mass Index(kg/m2) | Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 | Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 | Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 32.482 ± 7.398 | 31.823 ± 7.087 | 31.101 ± 7.192 | 33.401 ± 8.190 | 32.405 ± 5.234 | 31.659 ± 7.236 | 32.150 ± 7.047 |
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Studies of the drug tested here: XT-150
Xalud Therapeutics, Inc.