NCT06108544

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study With a Randomized Withdrawal and Retreatment Period to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,108 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 weeks.

Detailed description

The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis. The study will enroll approximately 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need): * TAK-279 * Apremilast * Placebo This multi-center trial will be conducted worldwide. The overall time to participate in this study is 69 weeks. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 60 weeks. There will be a safety follow-up visit 4 weeks after their last day of treatment.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	TAK-279	Specified drug on specified days.
DRUG	Placebo	Specified drug on specified days.
DRUG	Apremilast	Specified drug on specified days.

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-12-06
• Completion: 2025-11-07
• First posted: 2023-10-31
• Last updated: 2025-11-20

Locations

217 sites across 16 countries: United States, Argentina, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Latvia, Poland, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study