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A Randomised, Double-blind, Placebo-controlled Trial for Establishing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of Multiple Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

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Trial Profile

A Randomised, Double-blind, Placebo-controlled Trial for Establishing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of Multiple Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 25 Mar 2024

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At a glance

  • Drugs BI 655064 (Primary)
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 22 Mar 2019 Primary endpoint (ACR20 (American College of Rheumatology) response rate at week 12 (day 85) from the initiation of study treatment (Part 2)) has not been met as per results published in the Annals of the Rheumatic Diseases
    • 22 Mar 2019 Results published in the Annals of the Rheumatic Diseases
    • 16 Aug 2018 Results (n=40) published in the Journal of Clinical Pharmacology.
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