ABT494 in patients with Crohn's Disease

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.

• IRAS ID

  170160

• Contact name

  Simon Travis

• Contact email

  simon.travis@ndm.ox.ac.uk

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2014-003240-12

• Clinicaltrials.gov Identifier

  NCT02365649

• Duration of Study in the UK

  2 years, 8 months, 30 days

• Research summary

  This is a phase II, randomised, double-blind trial to determine the efficacy and safety of multiple doses of ABT-494 versus placebo in patients with Crohn’s Disease (CD) with a history of inadequate response to or intolerance to anti-TNF therapy. The pharmacokinetics (PK) of ABT-494 will also be monitored to assess the absorption, distribution, metabolism, and elimination of the study drug in the body.

  About 210 people with CD will participate in the study. Participants will be asked to visit their study doctor 13 times over a period of up to 60 weeks.

  Eligible patients will be randomly assigned, at the Baseline visit, to one of the following treatment groups:

  - Group 1: ABT-494 3 mg, twice daily
  - Group 2: ABT-494 6 mg, twice daily
  - Group 3: ABT-494 12 mg, twice daily
  - Group 4: ABT-494 24 mg, twice daily
  - Group 5: ABT-494 24 mg, once daily
  - Group 6: Placebo

  At week 16, patients will be again selected by chance to one of three doses of ABT-494:

  - Group 1: ABT-494 3 mg, twice daily
  - Group 2: ABT-494 12 mg, twice daily
  - Group 3: ABT-494 24 mg, once daily

  A number of assessments will be performed during the study including physical examinations, CD symptom assessments, endoscopy, bowel biopsy (if required), stool sample tests, tuberculosis assessment (which may include a chest x-ray), blood and urine tests and electrocardiograms (ECG). These assessments are performed as part of the evaluation to determine if the study drug is effective and safe.

  The study will be run at approximately 5 centres in the UK and is sponsored by AbbVie.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  15/SC/0213

• Date of REC Opinion

  15 Jun 2015

• REC opinion

  Further Information Favourable Opinion