Takeda’s investigational oral psoriasis drug zasocitinib has delivered superior skin-clearance results versus deucravacitinib in a Phase 3 head-to-head trial, while new long-term data showed durable responses and early improvements in itch and quality of life.

 

Results from three LATITUDE psoriasis studies showed zasocitinib outperforming deucravacitinib on key measures of skin clearance. The data also pointed to rapid and sustained responses with once-daily oral treatment.

 

“Psoriasis is a heterogeneous disease driven by multiple immune pathways and TYK2 plays a central role in regulating several key inflammatory signals,” said Chinwe Ukomadu, Senior Vice President and Head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. 

 

“Across our Phase 3 trials, zasocitinib demonstrated superiority versus two distinct oral therapeutic classes in addition to rapid, durable and consistent skin clearance across patient types and in high-impact, hard-to-treat areas. The totality of these results underscores its potential to redefine what patients and physicians can expect from an oral psoriasis treatment.”

 

In the Phase 3 LATITUDE Atlas head-to-head study, zasocitinib achieved statistical superiority over deucravacitinib across the primary and all key secondary efficacy endpoints.

 

The advantage emerged as early as week 8 and widened by week 16, when more than twice as many patients receiving zasocitinib achieved complete skin clearance.

 

PASI 100 at week 16: 36.5% of patients treated with zasocitinib achieved complete skin clearance, compared with 13.9% of those receiving deucravacitinib.

 

PASI 90 at week 16: 62.5% of zasocitinib-treated patients achieved at least 90% skin clearance, versus 34.0% with deucravacitinib.

 

sPGA 0 at week 16: 43.2% of patients receiving zasocitinib achieved clear skin, compared with 18.5% in the deucravacitinib group.

 

Takeda said zasocitinib was generally well tolerated, with no new safety signals identified. Its safety and tolerability profile remained consistent with previous Phase 3 psoriasis studies. Across the LATITUDE trials, the most common adverse events included upper respiratory tract infection, nasopharyngitis and acne.

 

New longer-term findings from the pivotal LATITUDE PsO 3001 and 3002 studies showed that responses to zasocitinib could be sustained over time.

 

Among patients who had achieved a response at week 24, up to 93% maintained their skin-clearance response through week 52 in LATITUDE PsO 3001, based on a post-hoc analysis, and through week 40 in LATITUDE PsO 3002.

 

The studies also found that patients reported improvements in itch and quality of life as early as week 2, with benefits continuing through week 24.

 

At week 2, zasocitinib-treated patients experienced greater reductions from baseline in weekly mean Psoriasis Symptoms and Signs Diary (PSSD) symptom scores, including itch, compared with placebo and apremilast.

 

By week 4, more patients taking zasocitinib achieved a Dermatology Life Quality Index (DLQI) score of 0/1 — indicating that psoriasis had no effect on their quality of life — compared with placebo and, in LATITUDE PsO 3002, apremilast.

 

"Psoriasis affects patients in ways that extend well beyond visible skin lesions. Persistent plaques, uncontrolled itch and the unpredictability of flares can have a profound impact on sleep, daily activities and overall well-being, while the ongoing demands of managing the disease can place an additional burden on patients,” said Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health in Detroit and principal investigator for the LATITUDE Atlas study. 

 

"The data from the Phase 3 trials provide a more complete picture of once-daily oral zasocitinib, demonstrating rapid, durable and consistent skin clearance alongside meaningful improvements in itch and quality of life. Together, these findings underscore the potential of zasocitinib to deliver multiple outcomes that matter to patients and clinicians.”

 

Takeda said the combined Phase 3 findings support the potential of once-daily oral zasocitinib to provide rapid, durable and consistent disease control across patients with moderate-to-severe plaque psoriasis.