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

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: XT-150 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
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
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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Inactive comparator
 Biological: XT-150
plasmid DNA
Experimental: Low Dose XT-150
Low dose active, experimental treatment
 Biological: XT-150
plasmid DNA
Experimental: High Dose XT-150
High dose active, experimental treatment
 Biological: XT-150
plasmid DNA


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pain Interference [ Time Frame: 12 month ]
    Response rates in all dimensions of the short-form Brief Pain Inventory and Interference, lower scores indicate improvement

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124042


Contacts
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Contact: Michael Huston 9259978216 mhuston@xaludthera.com
Contact: Raymond Chavez, PhD 5103879261 rchavez@xaludthera.com

Locations
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United States, California
Neurovations (Napa Pain Institute) Not yet recruiting
Napa, California, United States, 94558
Contact: Hilary Cromwell    707-252-9669    hilaryc@napasurgerycenter.com   
Principal Investigator: Eric Grisgby, MD         
United States, North Carolina
Carolinas Pain Institute Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Jill Brewer    336-765-6181 ext 146    JBrewer@ccrpain.com   
Principal Investigator: Leonardo Kapural, MD         
Australia, South Australia
University of Adelaide in collaboration with CMAX Clinical Research Pty Ltd Not yet recruiting
Adelaide, South Australia, Australia, 5005
Contact: Dianne Pepper    +61 8 7088 7900    dianne.pepper@cmax.com.au   
Principal Investigator: Mark Rickman, MD         
Sponsors and Collaborators
Xalud Therapeutics, Inc.
Investigators
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Study Chair: Stephen D Collins, MD Xalud Therapeutics, Inc.
More Information
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Responsible Party: Xalud Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04124042     History of Changes
Other Study ID Numbers: XT-150-2-0204
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xalud Therapeutics, Inc.:
Inflammation
Pain
Interleukin
Gene Therapy
plasmid DNA
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases