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A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

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Trial Profile

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2023

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At a glance

  • Drugs Ziritaxestat (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ISABELA 2
  • Sponsors Galapagos NV

Most Recent Events

  • 10 Dec 2023 Results of pooled analysis of two studies (ISABELA 1, NCT03711162; ISABELA 2, NCT03733444) assessing pharmacokinetic and pharmacodynamic data to determine whether the lack of efficacy could be attributed to insufficient exposure and/or target engagement, published in the Clinical Pharmacology and Therapeutics.
  • 09 May 2023 Results (n=1306 from studies ISABELA 1 and 2) assessing the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF published in the JAMA: the Journal of the American Medical Association
  • 16 Dec 2021 New source identified and integrated (Japan Pharmaceutical Information Center - Clinical Trials Information record: JapicCTI205364).

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