This clinical study focuses on treating moderate-to-severe plaque psoriasis, a chronic skin condition that causes raised, red, scaly patches on the skin. The study will evaluate a new medication called TAK-279 (zasocitinib) compared to apremilast (Otezla) and placebo. The main purpose is to determine how well TAK-279 works when taken as a daily oral tablet for 16 weeks in people with this type of psoriasis.
The study involves taking either TAK-279, apremilast, or placebo in the form of tablets that are swallowed. During the study, doctors will monitor how well the medications work by examining changes in the skin’s appearance and the extent of psoriasis coverage on the body. They will look at improvements in skin clearance and reduction in psoriasis symptoms.
The research will include periods where some participants may switch between different treatments to better understand how the medication works over time. The study will track various aspects of psoriasis, including how it affects the scalp, nails, hands, and feet. Participants will be monitored for approximately 60 weeks to evaluate both the effectiveness and safety of the treatment.
1Initial treatment period
You will begin a 16-week treatment period receiving either TAK-279 tablets, apremilast tablets (Otezla), or placebo tablets once daily
The tablets should be taken by mouth
During this period, your skin condition will be regularly evaluated using special assessment tools that measure the extent and severity of psoriasis
2Week 16 evaluation
Your response to treatment will be assessed at week 16
The assessment will focus on how clear your skin has become and how much improvement you have experienced
The evaluation includes checking the percentage of improvement in your psoriasis symptoms
3Extended treatment period
Treatment continues until week 24
Additional assessments will be performed to evaluate ongoing response to treatment
Specific attention will be given to psoriasis on your scalp, nails, hands, and feet
4Randomized withdrawal period
At week 40, if you have achieved at least 75% improvement in your symptoms, you will enter a withdrawal period
During this time, some participants will continue treatment while others will stop
This period continues until week 60
5Final evaluation
The study concludes with final assessments of your psoriasis symptoms
The total duration of participation may last until mid-2026
Throughout the study, regular evaluations will track any changes in your skin condition
Who Can Join the Study?
You must be 18 years or older at the time of giving consent
You must have been diagnosed with plaque psoriasis for at least 6 months before screening
Your psoriasis must be stable (no significant changes) for at least 6 months before screening
You must have moderate to severe plaque psoriasis as determined by specific measurement scores (PASI score ≥12 and sPGA score ≥3)
Your psoriasis must cover at least 10% of your body surface area
You must be suitable for receiving phototherapy (light therapy) or systemic therapy (medication that affects your entire body)
You must be willing and able to follow all study procedures, including using digital tools and applications
You must provide written informed consent before starting any study procedures
If you are able to become pregnant, you must either:
Be post-menopausal (confirmed by laboratory tests), or
Use highly effective birth control methods during the study and for 10 days after the last dose
If you use oral contraceptives, you must use an additional form of birth control (preferably a male condom) during the study and for 10 days after the last dose
If you are 65 years or older, your doctor must determine that the benefits of participating outweigh the risks
If you currently smoke or have a long history of smoking (20 pack-years or more), your doctor must determine that the benefits of participating outweigh the risks
Who Cannot Join the Study?
Age below 18 years or above 65 years
Currently pregnant or breastfeeding women
History of serious allergic reactions to medications
Active or chronic infections, including tuberculosis (a bacterial infection primarily affecting the lungs)
Significant heart, liver, or kidney disease
Current diagnosis of cancer or history of cancer in the past 5 years
Use of other systemic medications (medications that affect the entire body) for psoriasis within the past 4 weeks
Use of topical treatments (creams, ointments applied to skin) for psoriasis within the past 2 weeks
Participation in other clinical trials within the past 30 days
History of substance abuse within the past year
Unstable mental health conditions
Severe infections requiring hospitalization within the past 3 months
TAK-279 is an experimental oral medication taken once daily that is being studied for treating moderate-to-severe plaque psoriasis. This is a new drug that is still being tested to see how well it works in reducing psoriasis symptoms. Unlike many psoriasis treatments that are applied to the skin or given as injections, this medication is taken by mouth.
The trial includes a placebo for comparison, which is a tablet that looks identical to TAK-279 but contains no active medication.
Note: The study is described as having an active comparator, but the specific medication used as the active comparator is not mentioned in the provided data.
Plaque Psoriasis – A chronic autoimmune skin condition that causes cells to build up rapidly on the surface of the skin. These excess cells form thick, silvery scales and itchy, dry, red patches that can be painful. The patches most commonly appear on the scalp, knees, elbows, and lower back, though they can occur anywhere on the body. The condition typically goes through cycles, flaring for a few weeks or months, then subsiding for a time. Plaque psoriasis is characterized by raised, inflamed patches of skin covered by silvery white scales, which can crack and bleed. The condition can vary in severity, from a few spots of dandruff-like scaling to major eruptions that cover large areas of the body.
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