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Follow on Extension of XT-150-1-0201

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ClinicalTrials.gov Identifier: NCT03769662
Recruitment Status : Enrolling by invitation
First Posted : December 7, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Xalud Therapeutics, Inc.

Brief Summary:
XT-150 safety and efficacy in severe osteoarthritic pain.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: XT-150 Phase 1

Detailed Description:

XT-150-1-0201 Extension: Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain.

Participants in this study will have been enrolled in the 0201 study and qualify for an intra-articular injection of XT-150 into the osteoarthritic knee.

The study will assess XT-150 safety, tolerability, and efficacy in participants who received placebo in the 0201 study, or have a second qualifying knee, or a second injection into the same knee that was treated in 0201.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single dose study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XT-150-1-0201 Extension: Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose from study XT-150-1-0201
Open label administration of the highest dose in the earlier study, in which all doses were well tolerated
Biological: XT-150
IL-10 transgene DNA plasmid injected into the knee synovial capsule




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]
    Clinical Pathology, adverse events


Secondary Outcome Measures :
  1. Verbal Numeric Rating Score [ Time Frame: 6 months ]
    Pain scale from 1 to 10, 10 being worst possible

  2. KOOS [ Time Frame: 6 months ]
    Osteoarthritis pain, symptoms, impact on daily living, and quality of life. Subset scores are calculated such that 100% is normal function

  3. Brief Pain Inventory [ Time Frame: 6 months ]
    Pain and interference on daily living functions. Scales ranges from 0 to 10, with 10 being the worst

  4. Clinical Global Improvement [ Time Frame: 6 months ]
    0 - 7 Scale, 4 and below indicate no change or improvement. Over 4 indicates degrees of worsening



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Qualified and participated in clinical study XT-150-1-0201.

    1. Participant was assigned to placebo, or
    2. Participant elects to have XT-150 administered to the XT-150-untreated knee that qualified under XT-150-1-0201 criteria, or
    3. Participant had inadequate pain relief and elects to receive a second injection to the same knee treated on clinical study XT-150-1-0201
  2. Sufficiently severe OA of knee to require/have recommended knee replacement surgery or be unsuitable for knee replacement surgery based on co-morbidities or orthopedic considerations; be free of local or intra-articular infection.
  3. Symptomatic disease because of osteoarthritis, defined as a Verbal Numerical Rating Scale (VNRS) scores of a worst pain of at least 7 at any time during the preceding week (based on scale of 0 to 10, with 10 representing "pain as bad as you can imagine").
  4. Stable analgesic regimen during the 4 weeks prior to enrollment.
  5. Inadequate pain relief (minimum ≥ 5 mean on Brief Pain Inventory-Severity Scale) lasting more than 3 months.
  6. In the judgment of the Investigator, acceptable general medical condition
  7. Life expectancy >6 months
  8. Male participants who are heterosexually active and not surgically sterile must agree to use effective contraception, including abstinence, for the duration of the study and for 3 months after the study is completed.
  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 reliably provide pain assessment
  12. 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. Scheduled knee replacement within 4 months; participant agrees not to schedule a knee replacement appointment within 4 months of study treatment
  3. History of rheumatoid arthritis of the knee or gout.
  4. High peri-operative risks which in the judgment of the investigator preclude a safe knee injection procedure (e.g., poorly controlled diabetes, cardiac inadequacy such as NYHA class > II, G4 glomerular filtration rate [eGFR < 30 mL/min by Cockcroft-Gault])
  5. Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
  6. History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months.
  7. Currently receiving systemic chemotherapy or radiation therapy for malignancy
  8. 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, lactate dehydrogenase)
  9. Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion indicated), uncontrolled coagulopathy (Grade 1, prolonged activated partial prothrombin time (aPTT) > upper limit of normal (ULN) to 1.5xULN), or bleeding diathesis, 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)
  10. Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
  11. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
  12. Current treatment with anticoagulants, other than low-dose aspirin.
  13. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
  14. Women of child-bearing potential
  15. Use of any investigational drug, other than XT-150, or device within 1 month 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.
  16. Any condition that, in the opinion of the Principal Investigator, could compromise the safety of the participant, the participant's ability to communicate with the study staff, or the quality of the data

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): NCT03769662


Locations
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Australia, South Australia
CMAX Clinical Research Pty Ltd in collaboration with University of Adelaide
Adelaide, South Australia, Australia, 5005
Sponsors and Collaborators
Xalud Therapeutics, Inc.
Investigators
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Principal Investigator: Mark Rickman, MD University of Adelaide

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Responsible Party: Xalud Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03769662     History of Changes
Other Study ID Numbers: XT-150-1-0203
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: December 2018
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
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Xalud Therapeutics, Inc.:
Cytokines
Anti-inflammatory
Pain
Inflammation

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases