A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

Trial Profile

A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2017

At a glance

  • Drugs Dusquetide (Primary)
  • Indications Mucositis
  • Focus Registrational; Therapeutic Use
  • Acronyms DOMINNATE
  • Sponsors Soligenix
  • Most Recent Events

    • 27 Jul 2017 Status changed from planning to recruiting, according to a Soligenix media release.
    • 03 May 2017 The company has received protocol clearance from the US FDA for this trial. This trial is expected to begin in the second quarter of 2017, according to a Soligenix media release.
    • 03 May 2017 According to a Soligenix media release, the Scientific Advice from the EMA indicates that this trial, if successful, in conjunction with results from the Phase 2 dose-ranging study, generally will be considered sufficient to support a marketing authorization application (MAA) for potential licensure in Europe.
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