ABT 494 enters Phase III trials for RA- AbbVie

AbbVie has announced the start of a large Phase III clinical trial SELECT-COMPARE program to study the use of ABT-494, an investigational, once-daily, oral selective JAK1 inhibitor for the treatment of rheumatoid arthritis (RA). This program will include adult patients with inadequate responses (IR) to conventional or biologic disease-modifying antirheumatic drugs (DMARDs), as well as methotrexate-naive patients. SELECT-COMPARE is a double-blind, placebo-controlled and active controlled Phase III study designed to evaluate the safety and efficacy of ABT-494 in combination with MTX in adult patients with moderate to severely active RA who have had an inadequate response to prior treatment with MTX. The trial duration is 48 weeks with a target enrollment of 1,500 patients.

The first two trials out of the five Phase III ABT-494 clinical trials have opened for enrollment in the United States. One study will evaluate ABT-494 in combination with MTX in adult patients with moderate to severely active RA who have had an inadequate response to prior treatment with MTX, and will include HUMIRA (adalimumab) as an active comparator. The second study will include patients who have had an inadequate response or intolerance to conventional synthetic DMARDs. These studies will include assessments of safety and tolerability, as well as key measures of efficacy including ACR responses and levels of disease activity. The other three Phase III clinical trials will begin enrollment in early 2016 and will include patients with an inadequate response to biologics and patients who are MTX-naive.