A Study of AMG 181 in Moderate to Severe Crohn’s Disease

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

• IRAS ID

  111767

• Contact name

  Chuka Nwokolo

• Sponsor organisation

  Amgen Inc

• Eudract number

  2012-000529-31

• Research summary

  Crohn??s Disease is a condition characterized by inflammation of the colon with peak age of onset in young adulthood. Current treatment options for patients with moderate to severe disease are limited. AMG 181 is an investigational product, which means it has not been approved by an appropriate regulatory health agency (e.g. European Medicines Agency). It has been developed by Amgen as a possible treatment for Crohn??s Disease and other medical conditions. This is an international study looking at AMG181 at various doses and its effect on Crohn??s Disease. A Placebo(dummy tablet) will be used to compare the results. To begin, the participant will have some tests to see if they are eligible for the study. For the first 24 weeks, participants will not know what they have been assigned (AMG181 or Placebo). After week 24, or earlier if disease worsening criteria are met, all participants will be given AMG181 at the same dose for approximately 108 weeks. Once participants finish taking AMG181/Placebo they will have an early termination visit, then be contact every 6 months, from last dose, for 2 years for a telephone interview. During the study, participants will undergo a number of procedures, including: disease assessments, general and safety assessments (e.g. vital signs, medical examination, ECG (see A22), adverse events, other medications), participant completed assessments (questionnaires), urine and blood sample tests. Participants may take part in additional optional substudies: biomarker (to learn more about inflammatory diseases, like Crohn??s Disease, and the effects of AMG181), pharmacokinetic (determine how much AMG181 has been absorbed and used by body), pharmacogenetic (scientific methods to evaluate differences in DNA that flunce inflammatory disease and/or the responses individuals have to the same therapy) and White Blood Cell (count the number of white blood cells to learn more about Crohn??s Disease). The entire study is approximately 4.5 years in duration.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0670

• Date of REC Opinion

  25 Sep 2012

• REC opinion

  Favourable Opinion