M14-327 Ph 2 study in Crohn's Disease Extension study
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease
IRAS ID
194340
Contact name
Simon Travis
Contact email
Sponsor organisation
Abbvie Ltd
Eudract number
2015-003759-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 10 days
Research summary
Crohns Disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gastro-intestinal tract. Currently no known medical or surgical cure exists for CD. At present, the treatment objectives for CD involve reducing the symptoms, to reduce the inflammation and improve quality of life. ABT-494 is an investigational drug being developed to help treat patients with inflammatory diseases. All patients with CD who have previously completed the M13-740 study and meet all of the inclusion/exclusion criteria have the option to participate in this study. The study is to assess the long-term safety, efficacy and tolerability of ABT-494 in approximately 210 patients globally.
Patients will be evaluated for entry into this study at the final study visit (week 52) of the M13-740 study or up to 10 days following the last visit of the M13-740 study (week 0 of M14-327). All patients will receive one of two doses of ABT-494 (low dose and high dose) depending on what they were receiving during the previous M13-740 study. At or after 4 weeks of being in this study patients receiving low dose of ABT494 who experience inadequate response may be escalated to the high dose of ABT-494. At or after 4 weeks patients receiving high dose of ABT-494 who do not respond adequately to ABT-494 may be withdrawn from the study if the investigator feels it is in their best interests. Study visits will take place at week 0, 1 month after week 0, 3 months after week 0 and from there on every 3 months for up to 2 years or until the patient withdraws from the study (premature discontinuation). There will be a follow up phone call approximately 30 days after the last dose of study drug.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0538
Date of REC Opinion
24 Nov 2016
REC opinion
Further Information Favourable Opinion