AbbVie, a global biopharmaceutical company, announced the start of a large Phase 3 clinical trial 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.
"We continue to leverage our expertise in rheumatology and immunology to address the unmet needs of patients living with immune-mediated diseases, including those that fail to respond to the current standard of care," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We are optimistic that our robust Phase 3 clinical trial program, which dosed the first patient in December, will help us further understand the therapeutic potential of ABT-494 across multiple patient populations and achieve our goal of providing patients with best-in-class treatment options."
Data from the Phase 2 ABT-494 clinical trials, BALANCE-I and BALANCE-2, announced in September 2015, demonstrated the efficacy of ABT-494 across 6, 12 and 18 mg doses twice-daily, and 24 mg once-daily in RA patients with an inadequate response to prior anti-tumor necrosis factor (TNF-IR) or methotrexate (MTX-IR) treatment.
The first two trials out of the five Phase 3 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 3 clinical trials will begin enrollment in early 2016 and will include patients with an inadequate response to biologics and patients who are MTX-naive.
