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A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn's disease with an option for open-label treatment extension (CALDOSE-2)

Trial Profile

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn's disease with an option for open-label treatment extension (CALDOSE-2)

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2019

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At a glance

  • Drugs Vidofludimus calcium (Primary)
  • Indications Crohn's disease
  • Focus Proof of concept; Therapeutic Use
  • Acronyms CALDOSE-2
  • Sponsors Immunic
  • Most Recent Events

    • 07 Nov 2019 According to an Immunic Therapeutics media release, the company expects to initiate this trial in 2020, after completion of a full review of the interim dosing analysis from CALDOSE-1 (which will guide the definition of suitable dose strengths for CALDOSE-2), and onsulting with the appropriate regulatory authorities.
    • 12 Aug 2019 According to an Immunic media release, the company expects to initiate this study later in 2019.
    • 21 Jun 2019 According to an Immunic media release, all the preparations for this trial are in the advanced stage with anticipation of the interim dosing analysis of CALDOSE-1 in the third quarter of 2019, which will inform the dose selection for CALDOSE-2.
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