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Osteoarthritis, KneePhase 1NCT03477487

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 United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of Safety, Tolerability, and Efficacy of XT-150, a plasmid DNA with a variant of human IL-10 transgene. XT-150 will be a single injection into the knee synovial capsule for the Treatment of Osteoarthritic Pain. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
8 Jun 2018to 30 Sep 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
  • Sufficiently severe OA of the knee to meet accepted criteria for knee arthroplasty
  • Free of intra-articular infection, or infection at the injection site.
  • Symptomatic disease because of osteoarthritis, defined as one or more of the following Visual Analog Scale of Pain Intensity (VASPI) scores:
  • a worst pain of at least 70 at any time during the preceding week (based on scale of 0 to 100, with 100 representing "pain as bad as you can imagine").
  • a worst stiffness of at least 70 at any time during the preceding week (based on a scale of 0 to 100, with 100 representing "stiffness as bad as you can imagine").
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  • Stable analgesic regimen during the 4 weeks prior to enrollment.
  • Inadequate pain relief (minimum ≥5 mean on the Brief Pain Inventory-Severity Scale) lasting ≥3 months.
  • In the judgment of the Investigator, acceptable general medical condition
  • Life expectancy >6 months
  • Female subjects of child-bearing potential, and those <1 year post-menopausal, must be practicing effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm) or total abstinence from heterosexual intercourse for a minimum of 1 month before study drug administration and agree to continue prevention methods for 3 months after participation in the study is completed.
  • Male subjects 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

  • 1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
  • Subject plans knee arthroplasty within 4 months, irrespective of the outcome of the trial or other conservative therapies
  • High peri-procedural 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 immunosuppressives (steroid therapy equivalent to >10mg/day prednisone); or other strong immunosuppressant
  • History of systemic immunosuppressive therapy; steroids (equivalent to >10mg/day prednisone) in the last 3 months
  • Currently receiving systemic chemotherapy or radiation therapy for malignancy
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  • 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 who are pregnant or nursing
  • 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 subject, the subject's ability to communicate with the study staff, or the quality of the data

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Neurovations (Napa Pain Institute)

    Napa, California, 94558

Other trials in United States

About this study

Official title: Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain

Evaluation of Safety, Tolerability, and Efficacy of XT-150, a plasmid DNA with a variant of human IL-10 transgene. XT-150 will be a single injection into the knee synovial capsule for the Treatment of Osteoarthritic Pain.

Read the detailed description

Phase 1 dose escalation study to evaluate the safety, tolerability, and efficacy of a plasmid DNA encoding a variant of human IL-10. This 6-month study will follow subjects with severe osteoarthritis of the knee. Safety labs, physical exams, and blood levels of the IL-10 variant will be assessed for tolerability and any adverse events associated with the treatment.

Being tested
XT-150
Keywords
inflammation, Cytokines, Interleukin-10, Gene therapy
Medical subject headings
Osteoarthritis, Knee, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XT-150Biological

    Human IL-10 variant transgene in a plasmid DNA vector

Study groups in NCT03477487
Study groupRoleWhat they receive
Lowest doseExperimentalThe lowest dose of XT-150 in the escalation schedule
Receives: Biological: XT-150
Second doseExperimentalThe 2nd dose of XT-150 in the escalation sequence
Receives: Biological: XT-150
Third doseExperimentalThe 3rd dose of XT-150 in the escalation sequence
Receives: Biological: XT-150
Highest doseExperimentalThe highest dose of XT-150 in the escalation sequence
Receives: Biological: XT-150

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Clinical, laboratory measures of safety by CTCAE v4.0

    Measured: 6 months

Secondary outcomes (4)

  1. Visual Analog Scale of Pain Intensity

    Validated index of pain

    Measured: 6 months

  2. Knee Injury and Osteoarthritis Outcomes Scale

    KOOS

    Measured: 6 months

  3. WOMAC

    Western Ontario and McMasters University Osteoarthritis Index

    Measured: 6 Months

  4. Brief Pain Inventory

    Measure of pain associated with osteoarthritis

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2018
  2. Study start8 Jun 2018
  3. Primary completion19 Jul 2019
  4. Study completion30 Sep 2019

Resources

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
Non-randomised
Intervention model
Sequential
Model description
Ascending dose-ranging study
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03477487
Sponsor's protocol ID
XT-150-1-0202
Status last verified
Oct 2019
First submitted
13 Mar 2018
Last updated
8 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 United States.

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 16 inclusion and 16 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 8 Nov 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 United States. 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. 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?

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03477487.

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 8 Nov 2019.

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