CompletedPhase 2

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

United States, Australia289 participantsStarted 2020-02-14

Plain-language 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.

Who can participate

Age range

45 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 180

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

Timeframe: Day 180

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

Timeframe: Prior to second dose (Up to Day 180-Day 330)

Stage B: Number of Participants With AEs and SAEs

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

Trial details

NCT IDNCT04124042

SponsorXalud Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-26

Results submitted2024-11-20

View on ClinicalTrials.gov More Osteoarthritis, Knee trials

Who can participate

Age range

45 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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

Exclusion criteria

. 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)

What they're measuring

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

Timeframe: Day 180

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

Timeframe: Day 180

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

Timeframe: Prior to second dose (Up to Day 180-Day 330)

Stage B: Number of Participants With AEs and SAEs

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