Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain

NCT04466410 | Terminated Phase 1

• 1 other identifier: XT-150-1-0102
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

Brief Summary

Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain. Intrathecally administered, single injection.

Conditions

Neuropathic Pain

Keywords

XT-150; Plasmid Gene Therapy; IL-10

Outcome Measures

Primary Outcomes (8)

• Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events

  6 months

• Number of participants with abnormal vital signs

  6 months

• Number of participants with clinically significant abnormal physical examination findings

  6 months

• Number of participants with anti-interleukin (IL)-10 antibodies

  6 months

• Number of participants with IL-10 Protein

  6 months

• Number of participants with abnormal clinical and hematology parameters

  6 months

• Number of participants with plasmid DNA present in whole blood

  6 months

• Number of participants with cytokines in Cerebrospinal fluid

  6 months

Study Arms (4)

0.015 milligram (mg) XT-150

EXPERIMENTAL

0.015 mg of XT-150. Cohort 1 of the study

Biological: XT-150

0.15 mg XT-150

EXPERIMENTAL

0.15 mg of XT-150. Cohort 2 of the study

Biological: XT-150

0.45 mg XT-150

EXPERIMENTAL

0.45 mg of XT-150. Cohort 3 of the study

Biological: XT-150

Placebo

PLACEBO COMPARATOR

PBS for injection.

Biological: Placebo

Interventions

XT-150 BIOLOGICAL

Single bolus intrathecal injection

Also known as: IL-10 transgene plasmid DNA injected intrathecally

0.015 milligram (mg) XT-150; 0.15 mg XT-150; 0.45 mg XT-150

Placebo BIOLOGICAL

Placebo is a sterile phosphate-buffered saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Male or female, between 18 and 80 years of age, inclusive
• Clinical indication: Lumbar disk disease with no prior lumbar surgery with radicular pain symptoms and/or signs of compressive neuropathy
• At screening and baseline, a pain intensity score \> 60 using the visual analog scale of pain intensity \[VASPI\] (0-100 mm scale) and a participant reported history of pain in the past 3 or more months
• Medically stable as determined by the Principal Investigator in consultation with the Sponsor's Medical Monitor, based on pre-study medical history, physical examination, and clinical laboratory tests
• In the judgment of the Principal Investigator, acceptable vital signs: blood pressure; resting heart rate; respirations, and oral temperature
• Life expectancy \>6 months as determined by the Principal Investigator
• Female participants of child-bearing potential, and those \<1 year post-menopausal, must be practicing highly 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 vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full menstruation cycle before study drug administration and agree to continue abstinence for 1 full menstruation cycle after the study is completed
• Male participants who are heterosexually active, and not surgically sterile, must agree to use effective contraception for the duration of the study and for 1 month after the study is completed
• Stable medical regimen for ≥1 month before screening assessments
• Have suitable lumbar anatomy for intrathecal injection as determined by MRI or X-Ray in the last 6 months.
• Willing and able to return for the follow-up (FU) visits
• Able to read and understand study instructions, and willing and able to comply with all study procedures
• Adequately informed of the nature and risks of the study and give written informed consent before receiving any study specific assessments or procedures
• Stable use of non-prescription pain therapy, including massage, TENS, physiotherapy osteopathy, chiropractic and acupuncture for 2 months prior and throughout the study period

You may not qualify if:

• Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug
• Any spinal deformity preventing intrathecal injection or making intrathecal injection unsafe
• Prior history of lumbar surgery, including fusion and microdiscectomy
• History of epidural block or facet block or steroid injection in the last 6 months
• Current unstable angina, uncontrolled congestive heart failure, or \>1+ pitting edema of lower extremities
• History of acute myocardial infarction, transient ischemic attack, stroke, or seizure within 3 months of screening visit
• Severe chronic obstructive or restrictive pulmonary disease
• Current insulin dependent diabetes mellitus
• Current autoimmune conditions or documented immunodeficiency
• History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months
• Current treatment with systemic immunosuppressive (systemic corticosteroid therapy \[equivalent to \>10mg/day prednisone\] or other strong immunosuppressant)
• Current or history of central nervous system cancer
• Any malignancy (EXCEPTION: localized non-melanoma skin cancers) within 5 years before the screening visit or currently receiving systemic chemotherapy, radiation therapy, or a surgical stabilization procedure
• Significant hepatic disease as indicated by clinical laboratory results for the following: ≥3 times the upper limit of normal (ULN) for aspartate aminotransferase, alanine aminotransferase, ≥ 2.5 time ULN alkaline phosphatase, or ≥1.5 times ULN for total bilirubin)
• 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)

Sponsors & Collaborators

• Xalud Therapeutics, Inc.: lead

Study Sites (4)

Genesis Research Services

Newcastle, New South Wales, 2292, Australia

Location

CerCare

Wayville, South Australia, 5034, Australia

Location

Metro Pain Group

Clayton, Victoria, 3168, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Howard Rutman, MD,MBA

  Xalud Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo and active drug are identical in appearance. Randomization will be provided to an unblinded pharmacist. Dosing and clinical assessments will be blinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation by cohort following safety reviews

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 10, 2020
• Study Start: April 14, 2021
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)