Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

NCT ID: NCT04238793

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2023-10-18

Brief Summary

Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031

Detailed Description

This is a first-in-human (FIH), multicenter, double-blind, placebo-controlled, parallel-group, escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031 administered by transforaminal epidural injection to subjects aged 18 to 75 years with neuropathic pain due to LSR.

Conditions

Neuropathic Pain From Lumbosacral Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cohort 1

Dose 1 (low dose: 1×1011 VG/500 μL solution) or Placebo

Group Type: EXPERIMENTAL

KLS-2031

Intervention Type: DRUG

KLS-2031 administered by transforaminal epidural injection

Placebo

Intervention Type: OTHER

Normal Saline (0.9%) administered by transforaminal epidural injection

Cohort 2

Dose 2 (medium dose: 1×1012 VG/500 μL solution) or Placebo

Group Type: EXPERIMENTAL

KLS-2031

Intervention Type: DRUG

KLS-2031 administered by transforaminal epidural injection

Placebo

Intervention Type: OTHER

Normal Saline (0.9%) administered by transforaminal epidural injection

Cohort 3

Dose 3 (high dose: 1×1013 VG/500 μL solution) or Placebo

Group Type: EXPERIMENTAL

KLS-2031

Intervention Type: DRUG

KLS-2031 administered by transforaminal epidural injection

Placebo

Intervention Type: OTHER

Normal Saline (0.9%) administered by transforaminal epidural injection

Interventions

KLS-2031

KLS-2031 administered by transforaminal epidural injection

Intervention Type: DRUG

Placebo

Normal Saline (0.9%) administered by transforaminal epidural injection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

To participate in the study, subjects must have met the following criteria at Visit 1 (Screening,

Day -56 to Day -15):

1. The subject signed a written informed consent for study participation including the 1-year double-blind treatment period and 1-year, open-label, long-term extension period.

Informed consent must have been obtained before any screening activities are conducted.

2. The subject, male or female, must have been between the ages of 18 and 75 years, inclusive.

3. The subject must have had a body mass index of ≤35 kg/m².

4. The subject must have had a diagnosis of pain due to LSR, with all of the following characteristics:

1. The subject perceived pain in 1 or both lower limbs at areas that are consistent with the area innervated by the lumbar 4 or 5 or sacral 1 (L4, L5, S1) nerve roots, with or without other sensory symptoms in the affected areas (typically, the pain may have been perceived in the buttock, thigh, calf, leg, foot, or toes). If both limbs were affected, pain had to be asymmetrical (ie, pain worse in 1 limb).

2. Pain in the leg radiated to below the knee.

3. Pain in the leg was worse during rest and/or at night and not solely present upon walking.

4. The history of the pain suggested that the cause of the LSR was due to the injury of the lumbosacral nerve root(s) by degenerative disease of the vertebrae in the lumbosacral spine or associated soft tissues (including the intervertebral discs).

5. The duration of the pain since onset was ≥6 months.

6. Based on clinical history, the intensity of the neuropathic (leg) pain had been stable during the 4-week period before screening (the pain may have fluctuated and may have been worse at night or at rest but was present on most days of the week).

5. Pain in the leg (worse affected leg) was worse than pain in the back.

2. Radicular pain at more than 1 spinal level, unstable spine, spondylolisthesis (>Grade 1), spondylolysis, caudal equina syndrome, arachnoiditis, progressive neurological deficit, moderate to severe central spinal canal stenosis (congenital or acquired) from other origins, vertebral compression fracture(s).

3. Pain that was associated with a substantial somatic pain component in lower limbs or other parts of the body apart from the back (eg, non-neuropathic/musculoskeletal pain) or more than 1 cause or potential cause for pain symptoms in low limbs.

4. Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or osteoarthritis that in the investigator's opinion would have prevented the subject from reliably delineating or assessing his/her pain due to LSR. Note: Any question regarding the acceptability of the etiology of the neuropathic pain was to be discussed with the medical monitor.

2. Had lumbar stenosis with pain present solely upon walking. Presence of lumbar narrowing on MRI was acceptable if the pain was not solely present upon walking.

3. In the investigator's opinion, the subject was unable to reliably delineate or assess his/her own pain by anatomical location/distribution (eg, the subject could not reliably tell the difference between his/her back pain and lower limb pain and could not rate the intensity of each separately).

4. The subject had pain in the lower limbs solely upon walking and not at rest.

Exclusion Criteria

1. The subject had:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kolon Life Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Bertoch, MD

Role: PRINCIPAL_INVESTIGATOR

JBR Clinical Research

Locations

Kolon Investigative Site : CenExel JBR

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

KS-GIG-001-01

Identifier Type: -

Identifier Source: org_study_id