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A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 01 Aug 2024

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At a glance

  • Drugs Tulisokibart (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ARTEMIS-UC
  • Sponsors Merck & Co; Prometheus Biosciences

    • Most Recent Events

    • 12 Jan 2024 Planned End Date changed from 31 Aug 2026 to 30 Jun 2026.
    • 17 Oct 2023 Results assessing the molecular biomarkers from ARTEMIS-UC patient samples obtained before and after treatment with PRA023 compared to placebo control, presented at the 31st United European Gastroenterology Week.
    • 17 Oct 2023 Results of post-hoc analysis assessing the impact of PRA023 on health-related quality of life using the In-flammatory Bowel Disease Questionnaire (IBDQ-32), presented at the 31st United European Gastroenterology Week.

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