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

NCT04238793 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: KS-GIG-001-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuropathic Pain From Lumbosacral Radiculopathy

Keywords

Neuropathic pain from lumbosacral radiculopathy; Lumbosacral radiculopathy; LSR

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of KLS-2031

  Frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12-lead electrocardiograms (ECGs)

  Week 1, Week 2, Week 4, Week 12, Week 26, Week 52

Secondary Outcomes (14)

• Long-term safety and tolerability of KLS-2031

  Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 78, Week 104

• Local safety and tolerability (including AEs, clinical laboratory parameters, and physical examination) of administration by transforaminal epidural injectionepidural injection as measured by the occurrence of injection site reactions

  Week 1, Week 2, Week 4, Week 12, Week 26, Week 52

• Change from baseline in weekly mean of the average daily pain score

  Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104

• Change from baseline in Galer Neuropathic Pain Scale (Galer NPS)

  Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104

• Number and percentage of subjects who have ≥30% and ≥50% reduction from baseline in the average daily pain score (PI-NRS)

  Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Drug: KLS-2031; Other: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: KLS-2031; Other: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: KLS-2031; Other: Placebo

Interventions

KLS-2031 DRUG

KLS-2031 administered by transforaminal epidural injection

Cohort 1; Cohort 2; Cohort 3

Placebo OTHER

Normal Saline (0.9%) administered by transforaminal epidural injection

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To participate in the study, subjects must have met the following criteria at Visit 1 (Screening,
• Day -56 to Day -15):
• 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.
• The subject, male or female, must have been between the ages of 18 and 75 years, inclusive.
• The subject must have had a body mass index of ≤35 kg/m².
• The subject must have had a diagnosis of pain due to LSR, with all of the following characteristics:
• 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).
• Pain in the leg radiated to below the knee.
• Pain in the leg was worse during rest and/or at night and not solely present upon walking.
• 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).
• The duration of the pain since onset was ≥6 months.
• 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).
• Pain in the leg (worse affected leg) was worse than pain in the back.

You may not qualify if:

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

Sponsors & Collaborators

• Kolon Life Science: lead

Study Sites (1)

Kolon Investigative Site : CenExel JBR

Salt Lake City, Utah, 84107, United States

Location

Study Officials

• Todd Bertoch, MD

  JBR Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: January 23, 2020
• Study Start: April 16, 2020
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

US (1)