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

Phase 1

Terminated

• Conditions: Spinal Stenosis; Degenerative Spondylolisthesis
• Interventions: Other: Control; Drug: AK1320 MS

• Registration Number: NCT04483297
• Lead Sponsor: Asahi Kasei Pharma Corporation

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-23
• Study Start: 2020-11-18
• Primary Completion: 2023-11-27
• Study Completion: 2024-01-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control	Control	Local Autologous Bone + Posterior Fixation
AK1320 MS	AK1320 MS	AK1320 MS + Local Autologous Bone + Posterior Fixation

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events	24 months
Summary of Neurological Status	24 months	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.

Secondary Outcome Measures

Name	Time	Method
36-Item Short Form Survey (SF-36v2®)	24 months
Successful Fusion	24 months	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.
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
Oswestry Low Back Pain Disability Questionnaire (ODI)	24 months

Trial Locations

Locations (7)

Hôpital Sacré-Coeur de Montréal; 🇨🇦 Montreal, Quebec, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Québec Laval; 🇨🇦 Québec, Quebec, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada