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

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID: NCT04124042
Run by: Xalud Therapeutics, Inc.
People needed: 289
Starts: 2020-02-14
Expected to finish: 2022-04-26
Last updated by the study team: 2025-03-27

Who can join

Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

You may not qualify if…

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
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

Where it is running

eStudySite — La Mesa, California, United States
Neurovations (Napa Pain Institute) — Napa, California, United States
Source Healthcare — Santa Monica, California, United States
Carolinas Clinical Research Institute — Winston-Salem, North Carolina, United States
University of Adelaide in collaboration with CMAX Clinical Research Pty Ltd — Adelaide, South Australia, Australia
Alfred Health — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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