Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis

Trial Profile

Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Jun 2016

At a glance

  • Drugs GLPG 1205 (Primary)
  • Indications Ulcerative colitis
  • Focus Proof of concept; Therapeutic Use
  • Acronyms ORIGIN
  • Sponsors Galapagos NV
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 26 Jan 2016 According to a Galapagos NV media release, the company announced results of ORIGIN study.
    • 26 Jan 2016 According to a Galapagos NV media release, primary endpoint (Percentage of subjects achieving Mayo clinical remission at Week 8 as measured by Mayo score in the GLPG1205 group versus the placebo group (Mayo score less than or equal to 2 with no individual subscore exceeding 1 point and rectal bleeding score of 0). Change in Mayo of GLPG1205 vs placebo at week 8 compared to baseline) has not been met.
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