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A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

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Trial Profile

A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2024

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At a glance

  • Drugs Cobitolimod (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms CONCLUDE; Induction Study 1
  • Sponsors Flerie

Most Recent Events

  • 31 Jan 2024 This trial has been Discontinued in Austria, according to European Clinical Trials Database record.
  • 19 Jan 2024 According to an InDex Pharmaceuticals media release, company announced that remaining commitments for the company have been quantified, and the expected cash balance per March 31, 2024, amounts to SEK 180-190 million. The amount includes all closing costs for the phase III program CONCLUDE, even though activities for closing the phase III program will continue also after March 31, 2024.
  • 19 Jan 2024 According to an InDex Pharmaceuticals media release, the concluding results from the terminated Induction Study 1 of the phase III program CONCLUDE are expected in the latter part of February 2024 and will be communicated at that timepoint.

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