A Multi-centre, Randomized, Two-armed, Parallel Group and Evaluator-blinded Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Trial Profile

A Multi-centre, Randomized, Two-armed, Parallel Group and Evaluator-blinded Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Nov 2017

At a glance

  • Drugs Terbinafine (Primary)
  • Indications Onychomycosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Moberg Pharma
  • Most Recent Events

    • 20 Nov 2017 According to a Moberg Pharma media release, patient recruitment will be completed in North America in the summer of 2018 and in Europe in the second half of 2018. Topline results are expected approximately 15 months after completion of recruitment.
    • 20 Nov 2017 According to a Moberg Pharma media release, the company is replacing contract research organization (CRO) handling primary responsibility of this trial with TFS International which has now been tasked with finalizing the European study. In North America, the company will work with a subcontractor Novella Clinical.
    • 08 Aug 2017 According to a Moberg Pharma media release, enrolment for two phase 3 studies of MOB-015 has taken longer than expected and the company have taken a number of measures to speed up the process and are now on the right track, however enrolment will likely not be completed this year with somewhat higher costs as a result.
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