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Phase III trial of low-dose naltrexone for Crohn's disease

Trial Profile

Phase III trial of low-dose naltrexone for Crohn's disease

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2018

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At a glance

  • Drugs Naltrexone (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Immune Therapeutics
  • Most Recent Events

    • 26 Mar 2018 According to an Immune Therapeutics media release, the has agreed to continue the trial for another 40 weeks with periodic CDAI/PCDAI and safety through week 52 and plans to use Lodonal in both adult and pediatric subjects as an adjunct to the Standard of Care. The Company will be looking for labeling for patients 12 and over for remission at 12 weeks and long-term maintenance at 52 weeks.
    • 26 Mar 2018 According to an Immune Therapeutics media release, the company has agreed to modify our endpoints to use the CDAI/PCDAI definition of remission as the trial primary endpoint and endoscopy and symptoms as the key secondary endpoints. In addition, the Company has agreed to conduct a 52-week study and will measure the primary and secondary end points at week 12.
    • 26 Mar 2018 According to an Immune Therapeutics media release, the company has agreed to a number of changes to the trial protocols based on the FDA recommendations. The adult trial will now include patients 12 and over and our drug therapy will be used as an adjunct to the standard of care which will include biologists with the goal to improve outcome and safety to the standard of care existing therapies.
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