Deucravacitinib Not Associated With Clinical Remission for Patients With Moderate, Severe Ulcerative Colitis

The phase 2 LATTICE-UC study evaluating deucravacitinib for use in moderate to severe ulcerative colitis (UC) did not meet the primary efficacy endpoint of clinical remission at week 12, according to a press release from Bristol Myers Squibb. The study also failed to meet its secondary efficacy endpoints and no new safety signals were observed.

LATTICE-UC is a randomized, placebo-controlled, multicenter study with the primary endpoint of clinical remission. Secondary endpoints include clinical response, endoscopic response, and histological improvement at the time of evaluation.

“Deucravacitinib has been shown to be a highly effective, first-in-class, oral, selective TYK2 inhibitor in psoriasis and we have ongoing phase 3 trials exploring the potential of deucravacitinib in psoriatic arthritis,” said Samit Hirawat, MD, chief medical officer at Bristol Myers Squibb, in a press release. “While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical program in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases. Bristol Myers Squibb would like to thank the patients and investigators who were involved in the LATTICE-UC clinical trial.”

According to the investigators, deucravacitinib is the first and only selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. The drug was designed to selectively target TYK2 and inhibit signaling of interleukin (IL)-23, IL-12 and type 1 interferon. These cytokines are critical to the pathogenesis of multiple immune-mediated diseases. At therapeutic doses, deucravacitinib does not inhibit Janus kinase (JAK) Janus kinase (JAK)1, JAK2, or JAK3.

Bristol Myers Squibb plans to complete a full review of the data from LATTICE-UC. Further, the use of deucravacitinib in UC is also being evaluated in IM011-127, a second phase 2 trial that includes a higher dose of the drug. Deucravacitinib is currently being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel disease.

REFERENCE

Bristol Myers Squibb provides update on phase 2 study of deucravacitinib in patients with moderate to severe ulcerative colitis [news release]. Bristol Myers Squibb; October 7, 2021. Accessed October 8, 2021. https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Provides-Update-on-Phase-2-Study-of-Deucravacitinib-in-Patients-With-Moderate-to-Severe-Ulcerative-Colitis/default.aspx