Phase 3 study evaluating TAK-279 in moderate-to-severe plaque psoriasis subjects
Research type
Research Study
Full title
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
IRAS ID
1008439
Contact name
Jason Tackett
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
Clinicaltrials.gov Identifier
Research summary
Psoriasis is a skin disease that causes a rash with itchy, scaly patches. Psoriasis is a common, long-term (chronic) disease with no cure. It can be painful, interfere with sleep and make it hard to concentrate. Plaque psoriasis is the most common form of psoriasis. Its symptoms are dry skin lesions, known as plaques, covered in scales. They normally appear on elbows, knees, scalp and lower back, but can appear anywhere on the body. The plaques can be itchy or sore, or both.
TAK-279 is an experimental drug that is being developed by Takeda Development Center Americas, Inc,. The active ingredient in TAK-279 targets a substance (protein) in the body that is used by the immune system. This substance has been shown to be important in psoriasis.
This is a phase 3 clinical trial meaning TAK-279 has been tested in humans before. This study is being done to help answer the following questions:
o How safe is TAK-279 and what are the side effects it could cause?
o How does psoriasis respond to TAK-279?
o How does TAK-279 compare to apremilast and placebo? Apremilast is an approved treatment for psoriasis. A placebo is a treatment that looks exactly like the real study drug but has no active drug in it.
o How does the body process TAK-279?
This study is a randomised, double-blind study. This means participants will be placed into a group at random and they, nor the researchers will know if they are receiving TAK-279, apremilast or placebo.
This study will have about 1000 people participate, taking place at about 250 sites (hospitals or clinics) globally. Participants may be in the study for up to 69 weeks and will have around 20 visits overall throughout the study. Different study activities will be carried out at study visits to check the participant’s health and the effects of the study drug, for example blood samples will be taken and participants will be evaluated using questionnaires.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
23/WM/0256
Date of REC Opinion
2 Jan 2024
REC opinion
Further Information Favourable Opinion