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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04124042




Registration number
NCT04124042
Ethics application status
Date submitted
9/10/2019
Date registered
11/10/2019

Titles & IDs
Public title
Efficacy and Safety of XT-150 in Osteoarthritis of the Knee
Scientific 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
Secondary ID [1] 0 0
XT-150-2-0204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - XT-150
Treatment: Drugs - Placebo

Experimental: Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 - Low dose active in Stage A and Stage B

Experimental: Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 - Low dose active in Stage A, high dose active in Stage B

Experimental: Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150 - High dose active in Stage A, low dose active in Stage B

Experimental: Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150 - High dose active in Stage A and Stage B

Placebo comparator: Stage A: Placebo, Stage B: 0.15 mg/mL XT-150 - Inactive comparator in Stage A, low dose active in Stage B

Placebo comparator: Stage A: Placebo, Stage B: 0.45 mg/mL XT-150 - Inactive comparator in Stage A, high dose active in Stage B


Treatment: Other: XT-150
plasmid DNA

Treatment: Drugs: Placebo
Placebo is a sterile phosphate-buffered saline
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage A: Number of participants achieving 30% improvement from Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) pain score
Timepoint [1] 0 0
Up to Day 180
Primary outcome [2] 0 0
Stage A: Change from Baseline in WOMAC Pain Score at Day 180
Timepoint [2] 0 0
At Day 180
Primary outcome [3] 0 0
Stage A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timepoint [3] 0 0
Up to Day 180
Primary outcome [4] 0 0
Stage B: Number of participants with AEs and SAEs
Timepoint [4] 0 0
Up to Day 360
Secondary outcome [1] 0 0
Stage B: Change from Baseline in WOMAC Pain Score at Day 360
Timepoint [1] 0 0
At Day 360
Secondary outcome [2] 0 0
Stage A and Stage B: Change from Baseline in WOMAC function score
Timepoint [2] 0 0
Up to Day 360
Secondary outcome [3] 0 0
Stage A and Stage B: Change from Baseline in Brief Pain Inventory (BPI) of Interference score
Timepoint [3] 0 0
Up to Day 360
Secondary outcome [4] 0 0
Stage A and Stage B: Change from Baseline in Patients Overall Assessment (POA)
Timepoint [4] 0 0
Up to Day 360
Secondary outcome [5] 0 0
Stage A and B: Number of participants with presence of anti-interleukin (IL)-10 antibody
Timepoint [5] 0 0
Up to Day 360

Eligibility
Key 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
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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/mm^3; <LLN - 0.8 x 109 /L, neutrophils <LLN - 1500/mm^3; <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 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
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2022
Sample size
Target
Accrual to date
Final
289
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
University of Adelaide in collaboration with CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
5005 - Adelaide
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Xalud Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04124042