AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain

NCT03263611 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AMG0103-US-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

Brief Summary

This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted single injection of AMG0103 in subject with chronic discogenic lumbar back pain

Conditions

Degenerative Disc Disease

Keywords

disc degeneration; Intervertebral disc; discogenic pain; chronic discogenic lumbar back pain

Outcome Measures

Primary Outcomes (3)

• Safety: treatment-emergent adverse events (AEs)

  6 months

• Safety: data from 12-lead electrocardiograms

  6 months

• Safety: data from clinical laboratory evaluations (hematology, serum chemistry, coagulation, inflammation and immunology)

  6 months

Secondary Outcomes (11)

• Visual Analogue Scale (VAS) for pain

  6 months

• Oswestry Disability Index to assess Activity of Daily Living

  6 months

• Roland Morris Disability Questionnaire to assess Activity of Daily Living

  6 months

• Patient Global Impression of Change pain self-assessment scale to assess Quality of Life

  6 months

• SF-36 to assess Quality of Life

  6 months

Study Arms (4)

placebo

PLACEBO COMPARATOR

subject will receive single intradiscal injection of placebo

Drug: Placebo

AMG0103 low dose

EXPERIMENTAL

subject will receive single intradiscal injection of AMG0103 low dose

Drug: AMG0103

AMG0103 middle dose

EXPERIMENTAL

subject will receive single intradiscal injection of AMG0103 middle dose

Drug: AMG0103

AMG0103 high dose

EXPERIMENTAL

subject will receive single intradiscal injection of AMG0103 high dose

Drug: AMG0103

Interventions

Placebo DRUG

single intradiscal injection

placebo

AMG0103 DRUG

single intradiscal injection

AMG0103 high dose; AMG0103 low dose; AMG0103 middle dose

Eligibility Criteria

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

You may qualify if:

• Male or female, between 18 and 75 years of age, inclusive, and skeletally mature, in the opinion of the investigator.
• Has provided written informed consent before undergoing any study-specific procedures.
• Has chronic low back pain for at least 6 months, where back pain is greater than leg pain.
• Has separate low back pain and leg pain VAS scores within the following parameters:
• Average low back pain VAS score of at least 40 mm and less than 90 mm on a 100 mm visual analog scale.
• Average leg pain VAS score that is less than or equal to 50% of the average low back pain VAS score above, where leg pain VAS scores are measured on a 100 mm visual analog scale.
• Has had inadequate response to conservative medical care over a period of at least 3 months.
• Diagnosis of painful degenerative disc disease at one lumbar level from L1 to S1 confirmed by subject history and radiographic studies (eg, MRI, x-rays). Radiographic studies must demonstrate the following:
• A Pfirrmann score of 3 or 4 on MRI in just a single disc between L1 and S1
• With or without contained disc herniations of \<3 mm protrusion with no radiographic evidence of neurologic compression
• Disc height loss of the symptomatic disc is less than 50% of the adjacent discs
• All discs other than the index disc must have a Pfirrman score of less than 3
• No spondylolisthesis or instability on flexion/extension views of more than 1-2 mm
• No evidence of sacroiliac, or extra-spinal, pathology that could account for lumbar back pain
• No more fluid in, or widening of, the facet joints around the symptomatic disc than is seen on the other facet joints of "normal" levels

You may not qualify if:

• Has any prior or current medical condition (eg, an active systemic infection), including known bleeding disorders that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements.
• Has any clinically significant finding on a screening evaluation that in the judgment of the Investigator would preclude safe study completion.
• Liver function tests \>1.5 the upper limit of normal (ULN) for alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST)
• Serum creatinine \>1.5 ULN at screening
• Blood pressure \>160/110 mm Hg recorded on 3 readings at screening and/or resting pulse \>120 beats/min at screening
• Body temperature ≥101°F on day of planned injection
• Has a co-morbid medical condition of the spine or the upper extremities that may affect neurological and/or pain assessments as specified in the protocol, including spinal fusion, spondylolysis and spondylolisthesis.
• Has evidence of hip pathology based on clinical history, physical exam and/or radiographic imaging that could be the source of lumbar back pain.
• Has a history of an endocrine or metabolic disorder that affects the spine (eg, Paget's disease).
• Has a compressive pathology due to stenosis or frankly herniated disc or sequestered discs.
• Has symptomatic involvement of more than one lumbar disc, in the opinion of the investigator.
• Has an intact disc bulge/protrusion or focal herniation at the symptomatic level \>3 mm, the presence of disc extrusion or sequestration, or a complete annular tear.
• Has lumbar intervertebral foraminal stenosis at the symptomatic level resulting in clinically significant spinal nerve root compression, in the opinion of the investigator.
• Has undergone a previous surgery at the symptomatic disc, or has plans to do so within 6 months of receiving the dose of AMG0103, that has altered the structure of the target disc level, or is likely to do so (eg, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency, thermocoagulation).
• Has had any lumbar intradiscal injection procedure (eg, injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate). Discography may be performed, but must be done at least 3 weeks (or more) prior to the injection procedure in this study.

Sponsors & Collaborators

• AnGes, Inc.: lead

Study Sites (6)

Keck Medicine of USC

Los Angeles, California, 90033, United States

Location

University of California San Diego

San Diego, California, 92037, United States

Location

Spine Institute of San Diego

San Diego, California, 92120, United States

Location

Florida Medical Pain Management

St. Petersburg, Florida, 33709, United States

Location

Florida Medical Relief

Tampa, Florida, 33614, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Kato K, Akeda K, Miyazaki S, Yamada J, Muehleman C, Miyamoto K, Asanuma YA, Asanuma K, Fujiwara T, Lenz ME, Nakazawa T, An H, Masuda K. NF-kB decoy oligodeoxynucleotide preserves disc height in a rabbit anular-puncture model and reduces pain induction in a rat xenograft-radiculopathy model. Eur Cell Mater. 2021 Jul 20;42:90-109. doi: 10.22203/eCM.v042a07.

  PMID: 34284523 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• AnGes, Inc. Clinical Development

  AnGes, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 28, 2017
• Study Start: February 26, 2018
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (6)