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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04841512




Registration number
NCT04841512
Ethics application status
Date submitted
7/04/2021
Date registered
12/04/2021

Titles & IDs
Public title
Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis
Scientific title
A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain
Secondary ID [1] 0 0
XT-150-1-0301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Spine 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

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

Placebo comparator: Placebo - Sterile phosphate-buffered saline for injection Single 1mL injection into the facet joint

Experimental: XT-150 Dose #1 - Lower dose of XT-150 sterile solution for injection Single 1 mL injection into the facet joint

Experimental: XT-150 Dose #2 - Higher dose of XT-150 sterile solution for injection Single 1 mL injection into the facet joint


Treatment: Other: XT-150
non-viral Plasmid DNA encoding an IL-10 variant transgene
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual analog scale (VAS)
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Oswestry Disability Index
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
1. Male or female, between 18 and 90 years of age, inclusive.
2. Sufficiently severe facet arthropathy (OA) of lumbar facets as determined by imaging, eg. CT or MRI, to establish an underlying basis of disease, as determined by usual bony and ligamentous signs of OA.
3. Complaint of nociceptive, mechanical pain of lumbar spine, in particular pain localized to paramedian axis as opposed to midline or radicular. Radicular pain as a secondary finding may be allowed if it is addition to mechanical pain and can be clinically distinguished by subject
4. Low Back Pain (LBP) worsened by activity or motion of region
5. Have had a positive diagnostic facet pain block with lignocaine; admittance if subject gains 50% relief of pain within 30 minutes of test injection
6. Be free of local or intra-articular infection, tumor or other causes of localized LBP, for example Including spondylolysis/pars defect, and adjacent vertebral body compression fracture based on MRI evaluation.
7. Symptomatic disease because of osteoarthritis, established by imaging of facet joint and defined as a worst pain of at least 40 at any time during the preceding week (based on scale of 0 to 100, with 100 representing "pain as bad as you can imagine") using Visual Analog Scale (VAS).
8. Stable analgesic regimen during the 4 weeks prior to enrollment.
9. Inadequate pain relief (minimum =50 mean on VAS with prior therapies lasting =3 months.
10. In the judgment of the Investigator, acceptable general medical condition
11. Male and female participants who are heterosexually active and not surgically sterile or post-menopausal must agree to use effective contraception, including abstinence, for the duration of the study and for 3 months after the study is completed
12. Have suitable facet joint anatomy for intra-articular injection
13. Willing and able to return for the follow-up (FU) visits
14. Able to reliably provide pain assessment (FAST test score R2=0.7)
15. Able to read and understand study instructions, and willing and able to comply with all study procedures
Minimum age
18 Years
Maximum age
90 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. Scheduled surgical procedure or nerve ablation to joint within the next 6 months; participant agrees not to schedule a surgical procedure, nerve ablation, or added facet injection within 6 months of study treatment
3. High peri-operative risks which in the judgment of the investigator preclude a safe facet joint injection procedure (e.g. extreme obesity putting injection accuracy at risk, etc.)
4. Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
5. History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months.
6. Currently receiving systemic chemotherapy or radiation therapy for malignancy
7. 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)
8. 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)
9. Positive serology with reflex for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus within 4 weeks of commencing the study
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. Use of any investigational drug 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.
15. 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

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2022
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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
Not applicable. All patient records are de-identified


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/NCT04841512