Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03282149
Registration number
NCT03282149
Ethics application status
Date submitted
11/09/2017
Date registered
13/09/2017
Date last updated
5/07/2019
Titles & IDs
Public title
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain
Query!
Scientific title
A Placebo-controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of Ascending Doses of XT-150 for the Treatment of Osteoarthritic Pain
Query!
Secondary ID [1]
0
0
XT-150-1-0201
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - XT-150
Experimental: Dose 1 - Lowest trial dose of XT-150
Experimental: Dose 2 - Second, escalating dose of XT-150
Experimental: Dose 3 - Third, escalating dose of XT-150
Placebo Comparator: Saline placebo - 2 of 8 participants in each cohort will randomly be assigned to placebo
Other interventions: XT-150
IL-10 transgene DNA plasmid injected into the knee synovial capsule
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Incidence of Treatment-Emergent Adverse Events [Safety]
Query!
Assessment method [1]
0
0
Clinical Pathology, Adverse Events
Query!
Timepoint [1]
0
0
180 days post treatment
Query!
Secondary outcome [1]
0
0
Verbal Numerical Rating Scale
Query!
Assessment method [1]
0
0
0 - 10 Pain assessment
Query!
Timepoint [1]
0
0
180 days post treatment
Query!
Eligibility
Key inclusion criteria
1. Male or female, between 18 and 90 years of age, inclusive. Women who are not of
child-bearing potential in the same age range.
2. Sufficiently severe OA of knee to require/have recommended knee replacement surgery or
be unsuitable for 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 one or more of the following
Verbal Numerical Rating Scale (VNRS) scores:
1. 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").
2. a worst stiffness of at least 7 at any time during the preceding week (based on a
scale of 0 to 10, with 10 representing "stiffness as bad as you can imagine").
4. Stable analgesic regimen during the 4 weeks prior to enrollment.
5. Inadequate pain relief (mean >5 mean on Brief Pain Inventory-Severity Scale) from
prior therapies lasting 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
90
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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 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
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 10e9
/L, neutrophils <LLN - 1500/mm3; <LLN - 1.5 x 10e9 /L)
10. Positive serology for human immunodeficiency virus, hepatitis B virus, or hepatitis C
virus within 4 weeks of commencing the study
11. Significant neuropsychiatric conditions; dementia, major depression, or altered mental
state that in the opinion of the Investigator will interfere with study participation
12. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical
treatments)
13. Current treatment with anticoagulants, other than low-dose aspirin, prescribed for new
onset of symptoms in 3 months before screening visit.
14. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1
year before the screening visit
15. Women of child-bearing potential
16. 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.
17. Any condition that, in the opinion of the Principal Investigator, could compromise the
safety of the participant, the participant's ability to communicate the study staff,
or the quality of the data
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/03/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/06/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
24
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
CMAX Clinical Research Pty Ltd in collaboration with University of Adelaide - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
5005 - Adelaide
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Xalud Therapeutics, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of
Osteoarthritic Pain - Dose escalation
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03282149
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Mark Rickman, MD
Query!
Address
0
0
University of Adelaide
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03282149
Download to PDF