Illinois-based AbbVie, a global pharmaceutical company, has launched a robust Phase 3 clinical trial program to evaluate the investigational drug ABT-494 in the treatment of rheumatoid arthritis (RA).
The program will enroll adults with inadequate responses (IR) to biologic or conventional disease-modifying anti-rheumatic drugs (DMARDs), as well as methotrexate (MTX)-naive patients. The company will evaluate more than 4,000 patients over five Phase 3 trials.
“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,” AbbVie Vice President Scott Brun, M.D., said in a press release. “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.”
The first two trials comprised in the five-arm Phase 3 ABT-494 clinical trial include:
- The SELECT-NEXT Clinical Trial, which will evaluate 600 adult patients who have had an inadequate response or intolerance to synthetic DMARDs;
- The SELECT-COMPARE Clinical Trial, now open for enrollment in the U.S., which will evaluate the combination of ABT-494 with MTX in adult patients with moderate to severely active RA who have reported an inadequate response to prior treatment with MTX, using Humira (adalimumab) as a comparator. The target enrollment is 1,500 patients.
Both studies will include assessments of tolerability and safety as well as measurements of efficacy, including levels of disease activity and ACR responses.
The remaining three Phase 3 studies will enroll the first participants in early 2016 and intend to involve patients who are MTX-naïve and patients with an inadequate response to biologics.
Previously, data from the Phase 2 ABT-494 clinical trials – BALANCE-I and BALANCE-2 – announced in 2015, showed the efficacy of the oral selective JAK1 inhibitor ABT-494 in six, 12 and 18 mg doses twice-daily and 24 mg doses once a day in patients with RA and an inadequate response to methotrexate treatment or inadequate response to prior anti-tumor necrosis factor (TNF-IR).