Osteoarthritis, KneePhase 1NCT03282149
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain
A Phase 1 study testing XT-150 in people with Osteoarthritis, Knee, run by Xalud Therapeutics, Inc. at 1 site in Australia.
Trial summary
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain - Dose escalation Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- XT-150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Mar 2018to 15 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 90 years of age, inclusive. Women who are not of child-bearing potential in the same age range.
- 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.
- Symptomatic disease because of osteoarthritis, defined as one or more of the following Verbal Numerical Rating Scale (VNRS) scores:
- 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").
- 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").
- Stable analgesic regimen during the 4 weeks prior to enrollment.
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- Inadequate pain relief (mean >5 mean on Brief Pain Inventory-Severity Scale) from prior therapies lasting 3 months.
- In the judgment of the Investigator, acceptable general medical condition
- Life expectancy >6 months
- 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.
- Have suitable knee joint anatomy for intra-articular injection
- Willing and able to return for the follow-up (FU) visits
- Able to reliably provide pain assessment
- Able to read and understand study instructions, and willing and able to comply with all study procedures
Who cannot join
- Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
- Scheduled knee replacement within 4 months; participant agrees not to schedule a knee replacement appointment within 4 months of study treatment
- History of rheumatoid arthritis of the knee
- 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])
- Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
- History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months.
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- Currently receiving systemic chemotherapy or radiation therapy for malignancy
- 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)
- 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)
- Positive serology for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus within 4 weeks of commencing the study
- Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
- Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
- Current treatment with anticoagulants, other than low-dose aspirin, prescribed for new onset of symptoms in 3 months before screening visit.
- Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
- Women of child-bearing potential
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd in collaboration with University of Adelaide
Adelaide, South Australia, 5005
About this study
Official title: A Placebo-controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of Ascending Doses of XT-150 for the Treatment of Osteoarthritic Pain
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain - Dose escalation
Read the detailed description
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain.
Subjects for whom replacement knee surgery is recommended will be enrolled in the study. A single injection of a DNA plasmid with a variant Interleukin-10 (IL-10) transgene will be injected into the synovial capsule of the knee.
This is a first in human, dose-range, safety and efficacy study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- XT-150
- Keywords
- inflammation, cytokine, anti-inflammatory, pain
- Medical subject headings
- Osteoarthritis, Knee, Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XT-150Biological
IL-10 transgene DNA plasmid injected into the knee synovial capsule
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Lowest trial dose of XT-150 Receives: Biological: XT-150 |
| Dose 2 | Experimental | Second, escalating dose of XT-150 Receives: Biological: XT-150 |
| Dose 3 | Experimental | Third, escalating dose of XT-150 Receives: Biological: XT-150 |
| Saline placebo | Placebo comparator | 2 of 8 participants in each cohort will randomly be assigned to placebo Receives: Biological: XT-150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety]
Clinical Pathology, Adverse Events
Measured: 180 days post treatment
Secondary outcomes (1)
Verbal Numerical Rating Scale
0 - 10 Pain assessment
Measured: 180 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start21 Mar 2018
- Primary completion31 Mar 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Inflammation and pain due to osteoarthritis in the knee
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xalud Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Rickman, MD, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282149
- Sponsor's protocol ID
- XT-150-1-0201
- Status last verified
- Jul 2019
- First submitted
- 11 Sep 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified in a clinical trial database
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of Ascending Doses of XT-150 for the Treatment of Osteoarthritic Pain
- ClinicalTrials.gov ID
- NCT03282149
- Acronym / sponsor ID
- XT-150-1-0201
- Conditions
- Osteoarthritis, Knee
- Keywords
- inflammation, cytokine, anti-inflammatory, pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Xalud Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain - Dose escalation
Detailed description
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain.
Subjects for whom replacement knee surgery is recommended will be enrolled in the study. A single injection of a DNA plasmid with a variant Interleukin-10 (IL-10) transgene will be injected into the synovial capsule of the knee.
This is a first in human, dose-range, safety and efficacy study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Inflammation and pain due to osteoarthritis in the knee
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Biological: XT-150Lowest trial dose of XT-150 |
| Dose 2 | Experimental | Biological: XT-150Second, escalating dose of XT-150 |
| Dose 3 | Experimental | Biological: XT-150Third, escalating dose of XT-150 |
| Saline placebo | Placebo comparator | Biological: XT-1502 of 8 participants in each cohort will randomly be assigned to placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, between 18 and 90 years of age, inclusive. Women who are not of child-bearing potential in the same age range.
- 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.
- Symptomatic disease because of osteoarthritis, defined as one or more of the following Verbal Numerical Rating Scale (VNRS) scores:
- Stable analgesic regimen during the 4 weeks prior to enrollment.
- Inadequate pain relief (mean >5 mean on Brief Pain Inventory-Severity Scale) from prior therapies lasting 3 months.
Key exclusion criteria (17 listed)
- Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
- Scheduled knee replacement within 4 months; participant agrees not to schedule a knee replacement appointment within 4 months of study treatment
- History of rheumatoid arthritis of the knee
- 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])
- Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XT-150IL-10 transgene DNA plasmid injected into the knee synovial capsule | Biological | Dose 1, Dose 2, Dose 3, Saline placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 180 days post treatment
Clinical Pathology, Adverse Events
1 secondary outcome
Verbal Numerical Rating Scale
Time frame: 180 days post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No. All data will be de-identified in a clinical trial database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Rickman, MD principal investigator
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XT-150 in people with Osteoarthritis, Knee, run by Xalud Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety] (time frame: 180 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.