This study is in progress, not accepting new patients

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

a study on Psoriasis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA
Dates
study started
completion around
Principal Investigator
by April W. Armstrong, MD, MPH (ucla)
Headshot of April W. Armstrong
April W. Armstrong

Description

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 61 weeks.

Official Title

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

Details

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 600 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in a ratio of 3:1:1 to receive TAK-279, placebo, or apremilast which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  1. TAK-279
  2. Placebo
  3. Apremilast

This multi-center trial will be conducted worldwide. 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 52 weeks (1 year). There will be a safety follow-up visit 4 weeks after their last day of treatment.

Keywords

Plaque Psoriasis, Drug Therapy, Latitude Psoriasis 1, Latitude Research Program, Psoriasis, Apremilast, TAK-279

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Plaque psoriasis for at least 6 months.
  2. Moderate to severe disease.
  3. Candidate for phototherapy or systemic therapy.

You CAN'T join if...

  1. Other forms of psoriasis.
  2. History of recent infection.
  3. Prior exposure to TAK-279 or active comparator.

Other protocol defined inclusion/exclusion criteria apply.

Locations

  • UCLA University of California Los Angeles
    Los Angeles California 90024 United States
  • UC Davis Dermatology Clinic
    Sacramento California 95816-3370 United States
  • First OC Dermatology - Fountain Valley
    Fountain Valley California 92708-3701 United States

Lead Scientist at University of California Health

  • April W. Armstrong, MD, MPH (ucla)
    Dr. April Armstrong is Professor and Chief of Dermatology at University of California Los Angeles (UCLA). She oversees and leads the dermatology division, including managing clinical operations and promoting research and education. She also serves as Co-Director for Network Resources at the UCLA Clinical and Translational Research Institute.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
Links
More about this study
ID
NCT06088043
Phase
Phase 3 Psoriasis Research Study
Study Type
Interventional
Participants
About 693 people participating
Last Updated