Follow on Extension of XT-150-1-0201

NCT03769662 | Completed Phase 1 FDA Drug

• 1 other identifier: XT-150-1-0203
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

XT-150 safety and efficacy in severe osteoarthritic pain.

Conditions

Osteoarthritis, Knee

Keywords

Cytokines; Anti-inflammatory; Pain; Inflammation

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Clinical Pathology, adverse events

  6 months

Secondary Outcomes (4)

• Verbal Numeric Rating Score

  6 months

• KOOS

  6 months

• Brief Pain Inventory

  6 months

• Clinical Global Improvement

  6 months

Study Arms (1)

High dose from study XT-150-1-0201

EXPERIMENTAL

Open label administration of the highest dose in the earlier study, in which all doses were well tolerated

Biological: XT-150

Interventions

XT-150 BIOLOGICAL

IL-10 transgene DNA plasmid injected into the knee synovial capsule

High dose from study XT-150-1-0201

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Qualified and participated in clinical study XT-150-1-0201.
• Participant was assigned to placebo, or
• Participant elects to have XT-150 administered to the XT-150-untreated knee that qualified under XT-150-1-0201 criteria, or
• Participant had inadequate pain relief and elects to receive a second injection to the same knee treated on clinical study XT-150-1-0201
• Sufficiently severe OA of knee to require/have recommended 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 a Verbal Numerical Rating Scale (VNRS) scores of 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").
• Stable analgesic regimen during the 4 weeks prior to enrollment.
• Inadequate pain relief (minimum ≥ 5 mean on Brief Pain Inventory-Severity Scale) lasting more than 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

You may not qualify if:

• 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 or gout.
• 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.
• 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 109 /L, neutrophils \<LLN - 1500/mm3; \<LLN - 1.5 x 109 /L)
• 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.
• 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, other than XT-150, 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.

Sponsors & Collaborators

• Xalud Therapeutics, Inc.: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd in collaboration with University of Adelaide

Adelaide, South Australia, 5005, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Inflammation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Mark Rickman, MD

  University of Adelaide

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single dose study

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: March 20, 2019
• Primary Completion: October 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 18, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)