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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

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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Dec 2023

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At a glance

  • Drugs AMG 0101 (Primary)
  • Indications Back pain
  • Focus Adverse reactions; First in man
  • Sponsors AnGes

    • Most Recent Events

    • 29 Nov 2023 According to Anges media release, the company plan to confirm safety in the first two patients in the Phase I clinical trial in the U.S. (maximum dose 10 mg) to the maximum dose (20 mg) in the Phase II clinical trial in Japan.
    • 08 Oct 2021 Status changed from active, no longer recruiting to completed.
    • 17 Feb 2021 According to an AnGes media release, at this time, the company has completed their analysis of the 6-month data (Part 1) of this FDA-registered study, and additional results will be reported when the 12-month efficacy data are available. As the 12-month data becomes available the company will complete their analysis and report on those results as well.

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