A Study of AMG 181 in Moderate to Severe Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

• IRAS ID

  105809

• Contact name

  Chuka Nwokolo

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2011-005251-13

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Ulcerative Colitis is a disease 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 Ulcerative Colitis and other medical conditions. This is an international study looking at AMG181 at various doses and its effect on Ulcerative Colitis. A Placebo (dummy tablet) will be used to compare the results. To begin, the subject will have some tests to see if they are eligible for the study. For the first 24 weeks, eligible subjects will not know what they have been assigned (AMG181 or Placebo). After week 24, or earlier if needed, all subjects will be given AMG181 at the same dose for approximately 108 weeks. Once participants finish taking AMG181/Placebo they will be contacted in 3, and then every 6 months for up to two years to perform a safety follow up telephone interview. During the study, subjects will undergo a number of procedures, including: disease assessments, general and safety assessments (e.g. vital signs, medical examination, electrocardiogram, flexible simoidoscopy, adverse events, concomitant medication), subject completed assessments (questionnaires), urine and blood sample tests. Subjects may take part in additional optional substudies: biomarker (to learn more about inflammatory diseases, like Ulcerative Colitis, 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 Ulcerative Colitis) The entire study is approximately 4.5 years in duration.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0242

• Date of REC Opinion

  6 Sep 2012

• REC opinion

  Further Information Favourable Opinion