AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain
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
Doctors at several coordinating centers in IL, FL, and CA seek patients with chronic lower back pain due to disc degeneration to test a treatment that reduces inflammation through a therapy that can reduce genetic expression of inflammation.
Study participants will receive a low, medium, or high dose of this investigatory treatment via an intradiscal (between the discs) injection, with half of the participants receiving a placebo injection. Over the next several months, the patient will be assessed for pain reduction and X-rayed for disc space improvement, along with some lab assessments and MRIs.
- Have chronic lower back pain for at least 6 months that responded poorly to at least 3 months of medical care
- Be between the ages of 18 to 75 years
- Not be pregnant
- Using birth control from the time of enrollment on this study and for one year after treatment.
- No history of an endocrine or metabolic disorder that affects the spine (eg, Paget’s disease).
THE STUDY INVOLVES:
- Screening before the treatment, including lab tests and possibly MRI or X-ray.
- An intradiscal injection.
- Medical visits at 1 month and 6 months that will include pain assessment, ability assessment, X-ray, MRI, and lab and urine tests.
LOCATIONS AND CONTACTS:
The medical centers conducting this study are
Contact: Lena Galian 323-442-5303 [email protected]
Contact: Jesal Parekh 858-822-1288 [email protected]
Contact: Erin Mears 770-365-2555 [email protected]
Contact: Yulissa Peguero 727-548-6100 ext 280 [email protected]
Contact: Susan Dvojack 312-942-6689 [email protected]
AnGes, Inc. International Clinical Development
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