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Degenerative Disc DiseasePhase 1NCT03263611

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain

A Phase 1 study testing AMG0103 in people with Degenerative Disc Disease, run by AnGes, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Degenerative Disc Disease
What is being tested?
AMG0103
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
6 sitesUnited States
Study dates
26 Feb 2018to 15 Feb 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Has a Body Mass Index (BMI) between 15.0 and 35.0 kg/m2 at the screening visit.
  • Oswestry Disability Index score of at least 30 and not more than 90 on the 100 point questionnaire.
  • Willing and able to comply with all protocol requirements.
  • Females of childbearing potential must agree to use highly effective methods of contraception during heterosexual intercourse from the date they sign the ICF until 1 year after the single dose of study drug is administered.
  • Male subjects must agree that, if their partner is of childbearing potential, they and the partner will use an appropriate method of contraception as defined above.

Who cannot join

  • 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
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  • 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.
  • Has had any epidural steroid injection(s) within 3 months prior to study treatment.
  • Is a female who is pregnant, planning to become pregnant, or lactating.
  • Has a PT(INR) and/or aPTT lab result outside of the reference range, or within the last 30 days taken, or is currently on, an anticoagulant therapy (e.g., Warfarin) for the purpose of treating or preventing blood clots.
  • Has ferromagnetic implants that would disallow MRI of the symptomatic disc.
  • Is involved in current or pending spinal litigation where permanent disability benefits are being sought.
  • Has a physical or mental condition (eg, senile dementia, Alzheimer's disease) that would interfere with Subject self-assessment of function, pain or quality of life.
  • Has a positive screen for Hepatitis B Surface Antigen, Hepatitis C antibodies, or human immunodeficiency virus (HIV) by antibodies or nucleic acid test.
  • Is an immediate family member (by birth) of any other subject participating in this study.
  • Has a history of cancer that does NOT have documentation to support a complete and curative treatment.
  • Has participated within the previous 3 months in an interventional clinical study or is concurrently enrolled in any non-interventional research of any type judged to be scientifically or medically incompatible with this study.
  • Is transient or has been treated in the 6 months prior to providing informed consent for alcohol and/or drug abuse in an inpatient substance abuse program.
  • Is currently incarcerated (a prisoner).
  • Is an Investigator-site employee or immediate family (defined as a spouse, parent, child, or sibling, whether biological or legally adopted) of an Investigator-site employee.
  • Is a Sponsor employee (permanent, temporary contract worker, or designee responsible for the conduct of the study) or immediate family (defined as a spouse, parent, child, or sibling, whether biological or legally adopted) of a Sponsor employee.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Keck Medicine of USC

    Los Angeles, California, 90033

  • University of California San Diego

    San Diego, California, 92037

  • Spine Institute of San Diego

    San Diego, California, 92120

  • Florida Medical Pain Management

    St. Petersburg, Florida, 33709

  • Florida Medical Relief

    Tampa, Florida, 33614

Other trials in United States

About this study

Official title: A Phase 1b, Multicenter, Double-blind, Randomized, Placebo-controlled, Single Ascending-Dose, Clinical Study Evaluating the Safety, Tolerability and Exploratory Efficacy of a Targeted Single Injection of an Intradiscal Nuclear Factor-κB Decoy Oligodeoxynucleotide (AMG0103) in Subjects With Chronic Discogenic Lumbar Back Pain

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

Read the detailed description

This is a Phase 1b, multicenter, double-blind, single ascending dose study designed to evaluate the safety of AMG0103 in adult male and female subjects with chronic discogenic lumbar back pain.

This protocol anticipates that 8 subjects with symptomatic single level discogenic pain will be enrolled in each of up to 3 dose-escalation cohorts. Subjects in each cohort will receive AMG0103 or Placebo as a targeted, single, intradiscal injection.

Being tested
Placebo, AMG0103
Keywords
disc degeneration, Intervertebral disc, discogenic pain, chronic discogenic lumbar back pain
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    single intradiscal injection

  • AMG0103Drug

    single intradiscal injection

Study groups in NCT03263611
Study groupRoleWhat they receive
placeboPlacebo comparatorsubject will receive single intradiscal injection of placebo
Receives: Drug: Placebo
AMG0103 low doseExperimentalsubject will receive single intradiscal injection of AMG0103 low dose
Receives: Drug: AMG0103
AMG0103 middle doseExperimentalsubject will receive single intradiscal injection of AMG0103 middle dose
Receives: Drug: AMG0103
AMG0103 high doseExperimentalsubject will receive single intradiscal injection of AMG0103 high dose
Receives: Drug: AMG0103

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: treatment-emergent adverse events (AEs)

    Measured: 6 months

  2. Safety: data from 12-lead electrocardiograms

    Measured: 6 months

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

    Measured: 6 months

Secondary outcomes (11)

  1. Visual Analogue Scale (VAS) for pain

    Measured: 6 months

  2. Oswestry Disability Index to assess Activity of Daily Living

    Measured: 6 months

  3. Roland Morris Disability Questionnaire to assess Activity of Daily Living

    Measured: 6 months

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

    Measured: 6 months

  5. SF-36 to assess Quality of Life

    Measured: 6 months

  6. Disc space height by X-ray

    Measured: 6 months

  7. Pfirrmann Score by MRI

    Measured: 6 months

  8. PK of AMG0103: Cmax

    Maximum plasma concentration estimate for a single injection of AMG0103

    Measured: 1 month

  9. PK of AMG0103: Tmax

    Time to maximum plasma concentration estimate for a single injection of AMG0103

    Measured: 1 month

  10. PK of AMG0103: AUC

    Area under the plasma-concentration time curve (AUC) estimate for a single injection of AMG0103

    Measured: 1 month

  11. Amount of AMG0103 excreted into urine

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2017
  2. Study start26 Feb 2018
  3. Primary completion15 Feb 2021
  4. Study completion15 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03263611
Sponsor's protocol ID
AMG0103-US-01
Status last verified
Oct 2021
First submitted
16 Aug 2017
Last updated
12 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 34284523

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG0103 in people with Degenerative Disc Disease, run by AnGes, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: treatment-emergent adverse events (AEs) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03263611, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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