Lupus Therapeutics, AbbVie team up for Phase 3 trial of upadacitinib

Trial recruiting SLE patients and will be followed by long-term extension study

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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Lupus Therapeutics is partnering with AbbVie for the Phase 3 clinical program of upadacitinib for people with systemic lupus erythematosus (SLE).

“The partnership with AbbVie will support the accelerated evaluation of upadacitinib as a potential treatment for individuals living with SLE,” Stacie Bell, PhD, Lupus Therapeutics’ executive vice president, said in an emailed statement to Lupus News Today.

The Phase 3 SELECT-SLE trial (NCT05843643), which is at the core of the program, will evaluate the safety and efficacy of once-daily treatment with oral upadacitinib compared with a placebo, when given in combination with standard-of-care background therapy. The study is currently recruiting SLE patients and will be followed by a long-term extension study.

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Lupus Therapeutics will assist with participant recruitment, site activation, and engagement efforts, through the Lupus Clinical Investigators Network, which includes top academic research centers in North America.

“The collaboration between Lupus Therapeutics and AbbVie will tap into the expertise of clinical researchers in the Lupus Clinical Investigators Network to help facilitate and improve the clinical trial process in the evaluation of upadacitinib in SLE,” Bell said in a press release.

SLE, generally known as lupus, is the most common and severe form of the autoimmune disease, which has a wide array of symptoms, ranging from fatigue to life-threatening organ damage.

In the last 10 years, one treatment has been approved in the U.S. for SLE. Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, seeks to accelerate the development of potential treatments for a community in urgent need of more options.

The partnership with AbbVie will support the accelerated evaluation of upadacitinib as a potential treatment for individuals living with SLE.

Upadacitinib works by blocking the activity of Janus kinases, a family of enzymes involved in signaling pathways within immune cells. The therapy is expected to lower the activity of immune cells, thereby reducing the inflammation that drives lupus and other autoimmune conditions.

Marketed under the brand name Rinvoq, the treatment is approved in the U.S. for seven immune-mediated diseases, including arthritis, inflammatory bowel diseases, and dermatitis.

The advancement to the Phase 3 clinical program was backed by positive data from the Phase 2 SLEek trial (NCT03978520), which was designed to evaluate upadacitinib’s safety and efficacy in people with SLE who were also on standard therapies.

The trial also evaluated elsubrutinib, an experimental therapy that blocks a different protein in immune cells called Bruton’s tyrosine kinase. AbbVie is developing a combination of upadacitinib and elsubrutinib, called ABBV-599.

The study enrolled 341 adults with lupus, who received different doses of upadacitinib in combination with elsubrutinib, or one of the medications and a placebo version of the other therapy. Another group received only a placebo.

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Upadacitinib, ABBV-599 reduced disease activity in Phase 2 SLEek trial

The study achieved its main goal, with more patients given upadacitinib (30 mg) or high-dose ABBV-599 (30 mg upadacitinib/60 mg elsubrutinib) showing a significant reduction in disease activity, according to the SRI-4 composite measure of disease severity, after approximately six months. Specifically, 54.8% of those on upadacitinib and 48.5% on ABBV-599 achieved this goal, versus 37.3% in the placebo group.

Both treatment groups also significantly reduced lupus flares.

Side effects were generally consistent with the known safety profile of upadacitinib, and were similar for ABBV-599. Considering the combination therapy didn’t offer a substantial benefit over upadacitinib alone, it was decided not to be included in Phase 3 trials.

“It is extremely exciting to work with dedicated organizations like AbbVie as well as Biogen, BMS, Novartis and others on late-stage Phase 3 trials that hold promise for offering new treatment options for such a heterogeneous and impactful disease that affects our diverse community,” Bell said.