Osteoarthritis, KneePhase 2NCT04124042

Efficacy and Safety of XT-150 in Osteoarthritis of the Knee

A Phase 2 study testing XT-150 in people with Osteoarthritis, Knee, run by Xalud Therapeutics, Inc. at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 45 to 85 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: XT-150
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 289 participants
Where: 6 sitesin 2 countries
Study dates: 14 Feb 2020to 26 Apr 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic disease due to osteoarthritis, defined as a WOMAC Pain score ≥ 8 (worst possible = 20)
Focused Analgesia Selection Test will be used to determine whether patients can report pain with sufficient consistency to enter the clinical trial
Males and females between 45 and 85 years of age, inclusive
Kellgren-Lawrence grading of 2 or 3 within the last 6 months
Stable analgesic regimen during the 4 weeks prior to enrollment
In the judgment of the Investigator, acceptable general medical condition

Show all 11Show fewer

Life expectancy >6 months
Male and female participants who are heterosexually active and not surgically sterile must agree to use effective contraception, including abstinence, for the duration of the study
Have suitable knee joint anatomy for intra-articular injection
Willing and able to return for the follow-up (FU) visits
Able to read and understand study instructions, and willing and able to comply with all study procedures

Who cannot join

Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
Previously received XT-150 injection(s)
Scheduled partial or complete knee replacement within 6 months; participant agrees not to schedule a knee replacement during Stage A of the study
History of knee arthroplasty on the Index Knee, i.e., selected for study injection(s)
History of rheumatoid arthritis or other inflammatory disease
History of immunosuppressive therapy; systemic steroids in the last 3 months

Show all 19Show fewer

Received knee injection with hyaluronic acid or stem-cells in the last 6 months
Knee injection of glucocorticoid in the last 3 months
Current treatment with systemic immunosuppressive (systemic corticosteroid therapy or other strong immunosuppressant)
Currently receiving systemic chemotherapy or radiation therapy for malignancy
Clinically significant hepatic disease as indicated by clinical laboratory results ≥3 times the upper limit of normal for any liver function test (e.g., aspartate aminotransferase, alanine aminotransferase)
Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion indicated), Grade 1 white cell counts (lymphocytes <LLN - 800/mm^3; <LLN - 0.8 x 109 /L, neutrophils <LLN - 1500/mm^3; <LLN - 1.5 x 109 /L), LLN=Lower Limit Normal Range
Positive serology for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
Current anticoagulant or anti-platelet treatment (e.g., warfarin, heparins, factor X inhibitors, clopidogrel, prasugrel, ticagrelor, or dipyridamole). Low-dose (≤ 325 mg/day) aspirin is permitted
Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
Use of any investigational drug or device within 3 months before enrollment or current participation in a trial that included intervention with a drug or device; or currently participating in an investigational drug or device study
Any condition that, in the opinion of the Investigator, could compromise the safety of the participant, the participant's ability to communicate with the study staff, or the quality of the data

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States4 sites

eStudySite
La Mesa, California, 91942
Neurovations (Napa Pain Institute)
Napa, California, 94558
Source Healthcare
Santa Monica, California, 90403
Carolinas Clinical Research Institute
Winston-Salem, North Carolina, 27103

Other trials in United States

Australia2 sites

University of Adelaide in collaboration with CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5005
Alfred Health
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Double-Blind, Placebo-Controlled Assessment of the Tolerability and Efficacy of XT-150 for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee

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.

Read the detailed description

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:

0.15 mg/mL XT-150 (1mL), 0.15 mg/mL XT-150 (1mL)
0.15 mg/mL XT-150 (1mL), 0.45 mg/mL XT-150 (1mL)
0.45 mg/mL XT-150 (1mL), 0.15 mg/mL XT-150 (1mL)
0.45 mg/mL XT-150 (1mL), 0.45 mg/mL XT-150 (1mL)
Placebo (1mL), 0.15 mg/mL XT-150 (1mL)
Placebo (1mL), 0.45 mg/mL XT-150 (1mL)

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.

Conditions: Osteoarthritis, Knee
Being tested: XT-150, Placebo
Keywords: Inflammation, Pain, Interleukin, Gene Therapy, plasmid DNA
Medical subject headings: Osteoarthritis, Knee, Inflammation, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XT-150Biological
plasmid DNA
PlaceboDrug
Placebo is a sterile phosphate-buffered saline

Study groups in NCT04124042
Study group	Role	What they receive
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 Receives: Biological: XT-150
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 Receives: Biological: XT-150
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 Receives: Biological: XT-150
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 Receives: Biological: XT-150
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150	Placebo comparator	Inactive comparator in Stage A, low dose active in Stage B Receives: Biological: XT-150; Drug: Placebo
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150	Placebo comparator	Inactive comparator in Stage A, high dose active in Stage B Receives: Biological: XT-150; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post Second Dose (Day 180-Day 330 through Day 360)

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202026 Apr 2022

First posted11 Oct 2019
Study start14 Feb 2020
Primary completion26 Apr 2022
Study completion26 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04124042
Sponsor's protocol ID: XT-150-2-0204
Status last verified: Jan 2025
First submitted: 9 Oct 2019
Last updated: 27 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40826764

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Assessment of the Tolerability and Efficacy of XT-150 for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT04124042
Acronym / sponsor ID: XT-150-2-0204
Conditions: Osteoarthritis, Knee
Keywords: Inflammation, Pain, Interleukin, Gene Therapy, plasmid DNA
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 289 participants (actual)
Lead sponsor: Xalud Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 14 Feb 2020 (actual)
Primary completion: 26 Apr 2022 (actual)
Study completion: 26 Apr 2022 (actual)
First posted: 11 Oct 2019 (actual)
Results: Posted 27 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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:

0.15 mg/mL XT-150 (1mL), 0.15 mg/mL XT-150 (1mL)
0.15 mg/mL XT-150 (1mL), 0.45 mg/mL XT-150 (1mL)
0.45 mg/mL XT-150 (1mL), 0.15 mg/mL XT-150 (1mL)
0.45 mg/mL XT-150 (1mL), 0.45 mg/mL XT-150 (1mL)
Placebo (1mL), 0.15 mg/mL XT-150 (1mL)
Placebo (1mL), 0.45 mg/mL XT-150 (1mL)

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150	Experimental	Biological: XT-150Low 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	Biological: XT-150Low 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	Biological: XT-150High 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	Biological: XT-150High dose active in Stage A and Stage B
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150	Placebo comparator	Biological: XT-150, Drug: PlaceboInactive comparator in Stage A, low dose active in Stage B
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150	Placebo comparator	Biological: XT-150, Drug: PlaceboInactive comparator in Stage A, high dose active in Stage B

Who may qualify

Ages: 45 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Symptomatic disease due to osteoarthritis, defined as a WOMAC Pain score ≥ 8 (worst possible = 20)
Focused Analgesia Selection Test will be used to determine whether patients can report pain with sufficient consistency to enter the clinical trial
Males and females between 45 and 85 years of age, inclusive
Kellgren-Lawrence grading of 2 or 3 within the last 6 months
Stable analgesic regimen during the 4 weeks prior to enrollment

Key exclusion criteria (19 listed)

Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
Previously received XT-150 injection(s)
Scheduled partial or complete knee replacement within 6 months; participant agrees not to schedule a knee replacement during Stage A of the study
History of knee arthroplasty on the Index Knee, i.e., selected for study injection(s)
History of rheumatoid arthritis or other inflammatory disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
XT-150plasmid DNA	Biological	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
PlaceboPlacebo is a sterile phosphate-buffered saline	Drug	Stage A: Placebo, Stage B: 0.15 mg/mL XT-150, Stage A: Placebo, Stage B: 0.45 mg/mL XT-150

Primary outcome

Stage A: Number of Participants Achieving 30% Improvement From Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) Pain Score
Time frame: 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.
Stage A: Change From Baseline in WOMAC Pain Score at Day 180
Time frame: 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.
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Prior to second dose (Up to Day 180-Day 330)
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.
Stage B: Number of Participants With AEs and SAEs
Time frame: Post Second Dose (Day 180-Day 330 through Day 360)
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.

5 secondary outcomes

Stage B: Change From Baseline in WOMAC Pain Score at Day 360
Time frame: Day 360
Stage B: Change From Baseline in WOMAC Function Score
Time frame: At Day 360
Stage A: Change From Baseline in Brief Pain Inventory (BPI) of Interference Score
Time frame: Day 180
Stage A: Change From Baseline in Patients Overall Assessment (POA)
Time frame: Day 180
Stage A and B: Number of Participants With Presence of Anti-interleukin (IL)-10 Antibody
Time frame: Up to Day 360

Results and safety

Results posted to the registry on 27 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150	49	39
Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150	47	42
Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150	47	38
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150	47	39
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150	48	42
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150	48	43

Primary outcome: Stage A: Number of Participants Achieving 30% Improvement From Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) Pain Score

Time frame: Day 180. Count of participants. Unit: Participants

Measure	Stage A: 0.15 mg/ml XT-150 n = 95	Stage A: 0.45 mg/ml XT-150 n = 95	Stage A: Placebo n = 96
Responder	26	28	38
Non-responder	53	56	51
Not Analyzed	16	11	7

Stage A: 0.15 mg/ml XT-150 vs Stage A: Placebo: Odds Ratio (OR): 0.655 (95% CI 0.347 to 1.237)
Stage A: 0.45 mg/ml XT-150 vs Stage A: Placebo: Odds Ratio (OR): 0.714 (95% CI 0.381 to 1.336)

Population analysed: 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.

Primary outcome: Stage A: Change From Baseline in WOMAC Pain Score at Day 180

Time frame: Day 180. Least squares mean (Standard Error). Unit: score on a scale

Measure	Stage A: 0.15 mg/ml XT-150 n = 95	Stage A: 0.45 mg/ml XT-150 n = 95	Stage A: Placebo n = 96
Value	-1.77 (0.386)	-1.95 (0.380)	-2.21 (0.374)

Stage A: 0.15 mg/ml XT-150 vs Stage A: Placebo: Mean Difference (Final Values): 0.44 (95% CI -0.62 to 1.50), p = 0.413, Mixed Models Analysis
Stage A: 0.45 mg/ml XT-150 vs Stage A: Placebo: Mean Difference (Final Values): 0.26 (95% CI -0.79 to 1.31), p = 0.629, Mixed Models Analysis

Primary outcome: Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Prior to second dose (Up to Day 180-Day 330). Count of participants. Unit: Participants

Measure	Stage A: 0.15 mg/ml XT-150 n = 96	Stage A: 0.45 mg/ml XT-150 n = 94	Stage A: Placebo n = 96
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

Population analysed: The Safety Population will comprise all participants who receive any amount of study drug, analyzed according to treatment actually received.

Primary outcome: Stage B: Number of Participants With AEs and SAEs

Time frame: Post Second Dose (Day 180-Day 330 through Day 360). Count of participants. Unit: Participants

Measure	Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 n = 39	Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 n = 41	Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 n = 37	Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 n = 41	Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 n = 43	Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 n = 43
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

Population analysed: The Safety Population will comprise all participants who receive any amount of study drug, analyzed according to treatment actually received.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150	3 of 49 (6.1%)	15 of 49 (30.6%)	1 of 49
Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150	2 of 47 (4.3%)	16 of 47 (34%)	0 of 47
Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150	3 of 47 (6.4%)	18 of 47 (38.3%)	0 of 47
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150	2 of 47 (4.3%)	24 of 47 (51.1%)	0 of 47
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150	4 of 48 (8.3%)	10 of 48 (20.8%)	0 of 48
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150	3 of 48 (6.3%)	23 of 48 (47.9%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40826764Chen 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XT-150 in people with Osteoarthritis, Knee, run by Xalud Therapeutics, Inc. at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage A: Number of Participants Achieving 30% Improvement From Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) Pain Score (time frame: Day 180). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04124042, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.