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

Trial Profile

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

Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 31 Aug 2017

At a glance

  • Drugs NF kappa B Decoy-AnGes MG (Primary)
  • Indications Back pain
  • Focus Adverse reactions
  • Sponsors AnGes MG
  • Most Recent Events

    • 24 Aug 2017 Status changed from planning to not yet recruiting.
    • 25 Apr 2017 According to an AnGes media release, the US FDA has cleared the IND application for NF-kappaB decoy oligo DNA (NF-kappaB decoy) for the treatment of discogenic lower back pain (DLBP). The company plans to initiate a phase Ib clinical trial from the middle of this year at several clinical sites including University of California San Diego.
    • 24 Mar 2017 According to an AnGes media release, the company has submitted an IND application to the US FDA for initiating this trial.
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