First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) (ENHANCE)

First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) In Subjects With Degenerative Spondylolisthesis and Concomitant Symptomatic Spinal Stenosis Who Are Undergoing Decompression And Single Level Instrumented Posterolateral Lumbar Autograft Fusion Surgery

The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral lumber autograft fusion surgery.

Study Overview

• Status: Terminated
• Conditions: Spinal Stenosis; Degenerative Spondylolisthesis
• Intervention / Treatment: Drug: AK1320 MS; Other: Control

Detailed Description

This will be a first in human Phase I, ascending dose, multi-center, randomized patient study evaluating the efficacy, safety, PK of AK1320 MS. The study will enroll up to 4 dose escalating cohorts with each cohort having 2 treatment groups. Cohort 1 and Cohort 2 (AK1320 MS group (n=3-7); Control group (n=0-3)) and Cohort 3 and Cohort 4 (AK1320 MS group (n=6-7); Control group (n=0-3)).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
    • Montreal, Quebec, Canada, H4J 1C5
      • Hôpital Sacré-Coeur de Montréal
    • Québec, Quebec, Canada, G1J1Z4
      • Centre Hospitalier Universitaire de Québec Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Involved level L1 to S1
2. Use of local autologous bone only.
3. Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2.
4. Moderate or higher disability as assessed by Oswestry Disability Index.
5. Neurogenic claudication and/or radiculopathy with or without back pain.
6. Male or female over 22 years of age and less than 81 years of age.

Exclusion Criteria:

1. Prior lumbar decompression or spine fusion attempt (any level).
2. Undergoing concurrent interbody fusion.
3. Requires spinal fusion at more than one lumbar level.
4. Degenerative scoliosis.
5. BMI > 40.
6. Radiographically confirmed significant spinal instability.
7. Active or recent (within the past two (2) years) worker's compensation litigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK1320 MS; AK1320 MS + Local Autologous Bone + Posterior Fixation	Drug: AK1320 MS; AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.
Other: Control; Local Autologous Bone + Posterior Fixation	Other: Control; Local Autologous Bone + Posterior Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events		24 months
Summary of Neurological Status	Neurological status will be determined preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements: lower extremity motor, dermatomal sensation, reflexes and straight leg raise.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Fusion	Fusion will be evaluated through CT scans. Successful fusion will be defined as complete bridging bone between the index level transverse processes with a lack of lucency or lucent lines through the fusion mass.	24 months
Oswestry Low Back Pain Disability Questionnaire (ODI)		24 months
36-Item Short Form Survey (SF-36v2®)		24 months
AK1320 plasma concentrations		Pre-op(day 0), Post-op (day 0, day1), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks

Collaborators and Investigators

• Sponsor: Asahi Kasei Pharma Corporation
• Collaborators: Emergent Clinical Consulting, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: spinal stenosis; autograft; degenerative spondylolisthesis; posterolateral lumber fusion surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Constriction, Pathologic; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: AK1320-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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