A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study

This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study

Study Overview

• Status: Active, not recruiting
• Conditions: Lumbosacral Radiculopathy
• Intervention / Treatment: Drug: KLS-2031

Detailed Description

This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study (A Phase 1/2a, First-in-Human, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Therapeutic Activity of Single Ascending Doses of KLS-2031 Administered by Transforaminal Epidural Injection in Patients with Neuropathic Pain from Lumbosacral Radiculopathy). Following the end of the Open-label Safety Extension Period of the KS-GIG-001-01 Study (Visit 14), patients will enter the Long-term Follow-up Period. These patients will continue to be monitored for AEs (including AEs of special interest) and serious AEs (SAEs) via phone call every 6 months and outpatient visits every 52 weeks (annually), over 3 years.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Kolon Investigative Site : CenExel JBR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This long-term follow-up study will include up to 12 patients with neuropathic pain from LSR that have completed the KS-GIG-001-01 Study and were randomized to receive KLS-2031.

Description

Inclusion Criteria :

To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:

1. Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group
2. Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study

Exclusion Criteria :

To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:

1. Enrollment in another AAV or other gene therapy trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A group who administered KLS-2031 in the KS-GIG-001-01 Study	Drug: KLS-2031; KLS-2031 administered by transforaminal epidural injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.	Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.	Baseline through the end of study (approximately 3 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to each visit in Pain Intensity Numerical Rating Scale (PI-NRS) score = Result at week n - baseline, (n=52, 104, 156)	The PI-NRS is measured on an 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain) that the patient selects to best describe the intensity of pain that they have experienced in the last 24 hours.	Week 52, Week 104, Week 156
Change from baseline to each visit in Daily Sleep Interference Scale (DSIS) score = Result at week n - baseline, (n=52, 104, 156)	The DSIS has an 11-point numerical scale that asks the patient to assess how pain has interfered with their sleep during the past 24 hours. Response options range from 0 (does not interfere with sleep) to 10 (completely interferes with sleep).	Week 52, Week 104, Week 156
Change from baseline to each visit in Galer Neuropathic Pain Scale (Galer NPS) score = Result at week n - baseline, (n=52, 104, 156)	The Galer NPS is a relatively simple, self-administered, 10-item questionnaire for evaluating pain, which assesses distinct pain qualities associated with neuropathic pain.	Week 52, Week 104, Week 156
Change from baseline to each visit in modified Roland-Morris Disability Questionnaire (RMDQ) score = Result at week n - baseline, (n=52, 104, 156)	The modified RMDQ is a self-administered, 24-question physical disability measurement tool that evaluates both back and leg pain. Each of the 24 questions is asked 2 times, once with regard to back pain and once with regard to leg pain, for a total of 48 items. Each question requires a "yes" or "no" answer; 1 point is scored for each positive response. The total scores are determined on a scale of 0 to 24 for back pain and on a scale of 0 to 24 for leg pain, with 0 representing "no disability" and 24 representing "extreme disability."	Week 52, Week 104, Week 156

Collaborators and Investigators

• Sponsor: Kolon Life Science
• Investigators: Principal Investigator: Todd Bertoch, MD, JBR Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Lumbosacral Radiculopathy; LSR
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: KLS-2031LSRL001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No