Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124042
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xalud Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date November 8, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
Knee injury and Osteoarthritis Outcome Score(KOOS)/Western Ontario and McMasters Arthritis Index (WOMAC) [ Time Frame: 12 months ]
Responder Rates in KOOS/WOMAC scores, higher KOOS scores and lower WOMAC scores indicate improvement
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
Knee injury and Osteoarthritis Outcome Score(KOOS) [ Time Frame: 12 months ]
Responder Rates in KOOS/WOMAC scores
Change History Complete list of historical versions of study NCT04124042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • Pain Interference [ Time Frame: 12 month ]
    Response rates in all dimensions of the short-form Brief Pain Inventory and Interference, lower scores indicate improvement
  • Patient global assessment [ Time Frame: 12 months ]
    OA question, "Considering all the ways the OA in your knee affects you, how are you doing today?" on scale of 1-5, with 5 as worst
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Pain Interference [ Time Frame: 12 month ]
    Response rates in all dimensions of the short-form Brief Pain Inventory and Interference
  • Patient global assessment [ Time Frame: 12 months ]
    OA question, "Considering all the ways the OA in your knee affects you, how are you doing today?"
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of XT-150 in Osteoarthritis of the Knee
Official Title  ICMJE 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
Brief 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.
Detailed Description

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.

Baseline 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 knee.

Up to 270 participants will be randomly enrolled into 1 of 3 treatment groups (90 participants/ group). Treatment Groups:

  1. Placebo (1 mL)
  2. Low dose XT-150 (1 mL)
  3. High dose XT-150 (1 mL)

The study will be conducted in 2 stages, A and B:

A. Placebo-controlled for 6 months

B. Continued follow up for 6 months with the option of receiving one of two doses of XT-150 injection to the index knee.

Final assessments will be 12 months after the first IA dose.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, blinded, placebo-controlled, study of pain due to OA of the knee
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Biological: XT-150
plasmid DNA
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Inactive comparator
    Intervention: Biological: XT-150
  • Experimental: Low Dose XT-150
    Low dose active, experimental treatment
    Intervention: Biological: XT-150
  • Experimental: High Dose XT-150
    High dose active, experimental treatment
    Intervention: Biological: XT-150
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2019)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Symptomatic disease due to osteoarthritis, defined as a WOMAC Pain score ≥ 8 (worst possible = 20)
  2. Focused Analgesia Selection Test will be used to determine whether patients can report pain with sufficient consistency to enter the clinical trial
  3. Males and females between 45 and 85 years of age, inclusive
  4. Kellgren-Lawrence grading of 2 or 3 within the last 6 months
  5. Stable analgesic regimen during the 4 weeks prior to enrollment
  6. In the judgment of the Investigator, acceptable general medical condition
  7. Life expectancy >6 months
  8. 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
  9. Have suitable knee joint anatomy for intra-articular injection
  10. Willing and able to return for the follow-up (FU) visits
  11. Able to read and understand study instructions, and willing and able to comply with all study procedures

Exclusion Criteria:

  1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
  2. Previously received XT-150 injection(s)
  3. Scheduled partial or complete knee replacement within 6 months; participant agrees not to schedule a knee replacement during Stage A of the study
  4. History of knee arthroplasty on the Index Knee, i.e., selected for study injection(s)
  5. History of rheumatoid arthritis or other inflammatory disease
  6. History of immunosuppressive therapy; systemic steroids in the last 3 months
  7. Received knee injection with hyaluronic acid or stem-cells in the last 6 months
  8. Knee injection of glucocorticoid in the last 3 months
  9. Current treatment with systemic immunosuppressive (systemic corticosteroid therapy or other strong immunosuppressant)
  10. Currently receiving systemic chemotherapy or radiation therapy for malignancy
  11. 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)
  12. 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/mm3; <LLN - 0.8 x 109 /L, neutrophils <LLN - 1500/mm3; <LLN - 1.5 x 109 /L), LLN=Lower Limit Normal Range
  13. Positive serology for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
  14. Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
  15. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
  16. Current treatment with anticoagulants, other than low-dose (≤ 325 mg/day) aspirin, e.g., warfarin, heparins, factor X inhibitors
  17. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
  18. 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
  19. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Huston 9259978216 mhuston@xaludthera.com
Contact: Raymond Chavez, PhD 5103879261 rchavez@xaludthera.com
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04124042
Other Study ID Numbers  ICMJE XT-150-2-0204
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xalud Therapeutics, Inc.
Study Sponsor  ICMJE Xalud Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Stephen D Collins, MD Xalud Therapeutics, Inc.
PRS Account Xalud Therapeutics, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP