AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain
CompletedPhase 1NCT03263611
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted single injection of AMG0103 in subject with chronic discogenic lumbar back pain
Study details
- 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
- Conditions
- Interventions
- Drug: Placebo
- Drug: AMG0103
- Sponsor
- AnGes, Inc.
- Start date
- 2018-02-26
- Primary completion
- 2021-02-15
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Male or female, between 18 and 75 years of age, inclusive, and skeletally mature, in the opinion of the investigator. 2. Has provided written informed consent before undergoing any study-specific procedures. 3. Has chronic low back pain for at least 6 months, where back pain is greater than leg pain. 4. Has separate low back pain and leg pain VAS scores within the following parameters: 1. Average low back pain VAS score of at least 40 mm and less than 90 mm on a 100 mm visual analog scale. 2. 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. 5. Has had inadequate response to conservative medical care over a period of at least 3 months. 6. 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: 1. A Pfirrmann score of 3 or 4 on MRI in just a single disc between L1 and S1 2. With or without contained disc herniations of \<3 mm protrusion with no radiographic evidence of neurologic compression 3. Disc height loss of the symptomatic disc is less than 50% of the adjacent discs 4. All discs other than the index disc must have a Pfirrman score of less than 3 5. No spondylolisthesis or instability on flexion/extension views of more than 1-2 mm 6. No evidence of sacroiliac, or extra-spinal, pathology that could account for lumbar back pain 7. 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 7. Has a Body Mass Index (BMI) between 15.0 and 35.0 kg/m2 at the screening visit. 8. Oswestry Disability Index score of at least 30 and not more than 90 on the 100 point questionnaire. 9. Willing and able to comply with all protocol requirements. 10. 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. 11. 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. Exclusion Criteria: 1. Has any prior or current medical condition (eg, an active systemic infection), including known bleeding disorders that, in the judgment of…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03263611