NCT06550076

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,950 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times.

Detailed description

This study consists of 2 parts: Part A and Part B. Part A: Participants who did not participate in one of the parent studies (TAK-279-3001 \[NCT06088043\], TAK-279-3002 \[NCT06108544\], or TAK-279-PsO-3004 \[NCT06973291\]) may be enrolled and will be treated for up to 52 weeks. Participants who successfully complete Part A of the study are eligible to continue in Part B, but investigators must confirm their eligibility to continue in Part B. Part B: Participants who complete the treatment period of TAK-279-3001 (NCT06088043), TAK-279-3002 (NCT06108544), or TAK-279-PsO-3004 (NCT06973291) parent studies or who complete Part A are eligible to enroll directly into open label extension treatment in Part B and will be treated for up to 156 weeks.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	TAK-279	TAK-279 oral tablet

Timeline

• Start date: 2024-09-04
• Primary completion: 2026-05-07
• Completion: 2026-05-07
• First posted: 2024-08-12
• Last updated: 2026-01-15

Locations

278 sites across 20 countries: United States, Argentina, Australia, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study