M15-554- Comparing ABT-494 to Placebo in PsA subjects
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) – SELECT – PsA 2
IRAS ID
223376
Contact name
Toby Garrood
Contact email
Sponsor organisation
Abbvie Ltd
Eudract number
2016-004152-30
Duration of Study in the UK
4 years, 11 months, 6 days
Research summary
Psoriatic Arthritis (PsA) is a type of arthritis which develops in some people with the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. Currently patients have a range of options for treatment but these do not always have the desired or prolonged effect over the length of a patient’s life. This study is for patients who have moderate to severely active PsA and have had an inadequate response to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs). The study is comparing ABT-494 (an investigational drug) Dose A QD (once a day) and ABT-494 Dose B QD, with a placebo comparator to assess its safety, effectiveness and tolerability. It will include approximately 630 subjects in approximately 165 sites globally.
Patients will undergo a screening process up to 35 days after which they will enter Period 1 and follow a 56 week treatment phase, which includes 24-weeks of double-blind (neither the patient nor the doctors or study staff know), placebo-controlled treatment, followed by 32 weeks of blinded (unknown) treatment to dose of ABT-494. The patient is randomly assigned to one of 4 treatment groups: ABT-494 Dose A, ABT-494 Dose B, placebo followed by ABT-494 Dose A, or placebo followed by ABT-494 Dose B. At week 24 all patients on placebo will receive ABT-494 Dose A or Dose B.
Subjects who complete Period 1 will enter Period 2, an open-label (blinded until the last subject completes Period 1), long-term extension of up to a total treatment duration of approximately 3 years to evaluate the safety, tolerability and effectiveness of ABT-494 Dose A and Dose B in subjects who have completed Period 1.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0925
Date of REC Opinion
28 Jul 2017
REC opinion
Further Information Favourable Opinion