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.

Age range45 Years – 85 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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
✕. Received knee injection with hyaluronic acid or stem-cells in the last 6 months
✕. Knee injection of glucocorticoid in the last 3 months

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)

NCT IDNCT04124042

SponsorXalud Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-26

Results submitted2024-11-20

Who can participate

Age range45 Years – 85 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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
✕. Received knee injection with hyaluronic acid or stem-cells in the last 6 months
✕. Knee injection of glucocorticoid in the last 3 months

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)