Study of TAK-279 and apremilast for adults with moderate to severe plaque psoriasis

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What is this study about?

This study focuses on patients with moderate-to-severe plaque psoriasis, a chronic skin condition causing red, scaly patches on the skin that has been present for at least 6 months. The study will evaluate a new medication called TAK-279 (zasocitinib) compared to Otezla (apremilast) and placebo. All medications will be given as tablets that are taken by mouth once daily.

The main purpose is to determine how well TAK-279 works in treating plaque psoriasis over a 16-week period. The study will measure improvements in skin appearance and the extent of psoriasis coverage on the body. The total duration of treatment will be 52 weeks.

During the study, participants will be randomly assigned to receive either TAK-279, Otezla, or placebo tablets. The effectiveness of the treatment will be assessed by examining changes in the appearance and severity of psoriasis symptoms, including improvements in skin clearance and reduction in the affected areas. The study will also evaluate how the medications affect psoriasis on specific body areas such as the scalp, nails, hands, and feet.

1 Initial assessment and medication start

Your participation begins with an assessment of your plaque psoriasis condition using specific measurement tools to evaluate the severity of symptoms.

You will be randomly assigned to receive one of the following treatments: TAK-279 tablets, Otezla (apremilast) tablets, or a placebo tablet, all taken by mouth once daily.

If you receive Otezla, your treatment will start with a gradual dose increase: starting with 10 mg, then 20 mg, and finally reaching 30 mg tablets.

2 First treatment period – Week 1 to Week 16

You will take your assigned medication once daily by mouth for 16 weeks.

Regular evaluations will measure your skin condition using two main scales:

– The static Physician’s Global Assessment (sPGA), which measures the overall appearance of your psoriasis

– The Psoriasis Area and Severity Index (PASI), which measures the extent and severity of psoriasis

3 Extended treatment period – Week 16 to Week 24

Treatment continues for an additional 8 weeks.

During this period, additional assessments will track changes in your:

– Scalp psoriasis

– Nail psoriasis

– Affected body surface area

– Psoriasis on hands and feet

4 Final evaluation

At the end of the 24-week period, a final assessment will measure the overall effectiveness of the treatment.

The evaluation will include all previously measured aspects of your psoriasis condition.

Who Can Join the Study?

You must be 18 years or older at the time you agree to participate
You must have been diagnosed with plaque psoriasis for at least 6 months before screening
Your psoriasis must be stable (no major changes or flare-ups) for at least 6 months before screening
You must have moderate to severe plaque psoriasis as measured by specific assessment tools (PASI score of 12 or higher and sPGA score of 3 or higher)
Your psoriasis must cover at least 10% of your body surface area
You must be suitable for receiving phototherapy (light treatment) or systemic therapy (medicine that works throughout the body)
You must be willing and able to understand and follow all study procedures, including using digital tools and applications
You must provide written informed consent before any study procedures begin
If you can 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 sexually active
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

Who Cannot Join the Study?

History of serious infections or current active infections, including tuberculosis (TB – a bacterial infection affecting the lungs)
Current diagnosis of cancer or history of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
Significant heart problems including heart failure (when heart cannot pump blood effectively)
Active hepatitis B or C infection (viral infections affecting the liver)
Presence of other skin conditions that could interfere with evaluating psoriasis
Use of other psoriasis treatments within specified time periods before study start
Known allergic reactions to similar medications
Pregnant or breastfeeding women
Severe kidney or liver problems
Recent live vaccines (within 30 days before study start)
History of substance abuse within the past year
Any condition that could make it unsafe to participate in the study
Participation in another clinical trial within past 30 days
Major surgery planned during the study period

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
NZOZ LECZNICA MAK-MED s.c.	Nadarzyn	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Charite Research Organisation GmbH	Berlin	Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Promed P.Lach R.Glowacki Sp. j.	Cracow	Poland
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR	Blankenfelde-Mahlow	Germany
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
IRCCS Policlinico San Donato	San Donato Milanese	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Synexus Polska Sp. z o.o.	Poznan	Poland
Pratia S.A.	Skorzewo	Poland
Azienda USL Toscana Centro	Prato	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna	Warsaw	Poland
Mkbmfjnng Iotilfimbi Cxtgvzvf Slcugyza Sjl z omxp	Warsaw	Poland
Agrsygd Svxvmqzwy Lpoaej Abiwwzdk Shxxwqw Lnualptgylrxkh	L'aquila	Italy
Wmjrwjcp Pejwtv Dpnnnfnq Slyzyiyzebhwcgqngj I Neutbzcfluxaxez Omgxdel	Gdynia	Poland
Ugdbefkwudjxuwrzydutg Mapbgfnk Azz	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.05.2024
Italy	Not recruiting	01.05.2024
Poland	Not recruiting	01.05.2024

Trial locations

Investigated drugs:

TAK-279 is an oral medication (taken by mouth) that is being studied for treating moderate to severe plaque psoriasis. It is taken once daily and represents a new potential treatment option for patients with this skin condition. This medication is still being investigated to understand how well it works and how safe it is for patients with psoriasis.

Note: The trial also includes placebo and an active comparator, but their specific details are not provided in the source data.

Plaque Psoriasis – A chronic inflammatory skin condition characterized by raised, red patches covered with silvery-white scales. These patches typically appear on the elbows, knees, scalp, and lower back, but can affect any area of the body. The condition develops when skin cells multiply much faster than normal, causing the cells to build up on the surface. The patches (plaques) can be itchy, painful, and may crack or bleed. The severity can range from mild to severe, with moderate to severe cases covering larger areas of the body. The condition tends to go through cycles, with periods of flare-ups alternating with periods of remission.

Trial ID:

2023-505841-22-00

Protocol code:

TAK-279-3001

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of TAK-279 and apremilast for adults with moderate to severe plaque psoriasis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?