Study on the Effectiveness and Safety of ESK-001 and Apremilast for Adults with Moderate to Severe Plaque Psoriasis

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new treatment called ESK-001 for patients with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The study will compare the effects of ESK-001 with a placebo and an existing medication called Otezla, which contains the active ingredient apremilast. ESK-001 is taken as a tablet by mouth, and the study aims to see if it works better than the placebo after 16 weeks of treatment.

Participants in the study will be randomly assigned to receive either ESK-001, Otezla, or a placebo. The treatment period will last up to 24 weeks, during which participants will take the medication orally. The study will monitor the participants’ skin condition and overall health to assess the effectiveness and safety of the treatments. The goal is to determine if ESK-001 can significantly improve the symptoms of plaque psoriasis compared to the placebo and to evaluate its performance against Otezla.

The study is designed to provide valuable information about the potential benefits of ESK-001 for treating moderate to severe plaque psoriasis. By comparing it with a placebo and an existing treatment, researchers hope to understand how well ESK-001 works and its safety profile. This information could help in developing new treatment options for people living with this skin condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as age and the extent of your plaque psoriasis.

You will be informed about the trial’s procedures, and any questions you have will be addressed. Consent will be obtained to ensure you understand and agree to participate.

2 randomization

After the initial visit, you will be randomly assigned to one of the treatment groups. This means you may receive either the new medication ESK-001, a placebo, or an active comparator like Otezla (apremilast).

The assignment is random to ensure fairness and objectivity in the study results.

3 treatment phase

During the treatment phase, you will take the assigned medication orally. If you are in the ESK-001 group, you will take the medication as a tablet. If you are in the Otezla group, you will take either 10 mg, 20 mg, or 30 mg film-coated tablets.

The treatment will last for up to 16 weeks. You will be required to take the medication as directed by the study team, which will provide specific instructions on dosage and frequency.

4 follow-up visits

Throughout the trial, you will attend regular follow-up visits. These visits are important for monitoring your health and the effects of the treatment.

During these visits, various assessments will be conducted, including physical examinations and questionnaires about your condition and quality of life.

5 end of treatment evaluation

At the end of the 16-week treatment period, a final evaluation will be conducted. This will include assessments similar to those during the follow-up visits.

The purpose of this evaluation is to determine the effectiveness and safety of the treatment you received.

Who Can Join the Study?

  • Males or females, age 18 years or older
  • Diagnosis of plaque psoriasis for at least 6 months before the Screening Visit
  • Plaques covering at least 10% of the body surface area (BSA) at Screening and Day 1
  • PASI score of 12 or higher at Screening and Day 1 (PASI is a tool used to measure the severity and extent of psoriasis)
  • sPGA score of 3 or higher at Screening and Day 1 (sPGA is a scale used to assess the overall severity of psoriasis)
  • Women who can have children and men who are sexually active with such women must agree to use highly effective birth control methods throughout the study

Who Cannot Join the Study?

  • Patients with any other skin conditions that might interfere with the study results.
  • Patients who have used any other treatments for psoriasis within a certain period before the study starts.
  • Patients with a history of allergic reactions to similar medications.
  • Patients with any serious medical conditions that could affect their participation in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diamond Clinic Sp. z o.o. Cracow Poland
Technische Universitaet Dresden Dresden Germany
Hautarztpraxis Dr. Mihaescu Augsburg Germany
Sanatorium profesora Arenbergera Prague Czechia
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Futuremeds Sp. z o.o. Wroclaw Poland
Royalderm Agnieszka Nawrocka Warsaw Poland

Other Sites

Site Name City Country Status
Pratia Prague s.r.o. Prague Czechia
Praglandia s.r.o. Prague Czechia
Centre hospitalier universitaire de Liege Liege Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
FutureMeds GmbH Berlin Germany
Hospital Cuf Descobertas S.A. Lisbon Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Pratia Brno s.r.o. Brno-Stred Czechia
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Klinikum Bielefeld gGmbH Bielefeld Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Dermamedica s.r.o. Nachod Czechia
Klinikum Darmstadt GmbH Darmstadt Germany
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Rheuma Medicus Sp. z o.o. Warsaw Poland
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Siteworks GmbH Hanover Germany
Fakultni Nemocnice Plzen Plzen Czechia
Clintrial s.r.o. Prague Czechia
Clinmedica Research sp. z o.o. Skierniewice Poland
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Pratia Pardubice a.s. Pardubice Czechia
ProDerma Duelmen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Synexus Polska Sp. z o.o. Poznan Poland
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Pratia S.A. Skorzewo Poland
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
Majsszdod Iqmfhrxatm Csrzfvih Smknhjfd Sfy z owvm Warsaw Poland
Cbycsbrmo Uzixiuqvmhlgin Sbphssmot Woluwe-Saint-Lambert Belgium
Cjqxkjf Bnmdd Kninyyqkfim Pyzbewgm Skd z olxe Gdansk Poland
Toalllnnovr urp Stepwklazmn Btynceev Gdcr Bad Bentheim Germany
Dalcrrwa snhekj Povel Czechia
Koejj a kuzhivpjjm dglobflqaoaonu pcawwbicof Chomutov Czechia
Cffobs Zr Kgfdabneypxfbikpow Zkhqimqlxksx Eexh Sofia Bulgaria
Vtnzbgja sdmbpw Moravska Ostrava A Privoz Czechia
Milhyxi Cwlhlq Kmxfxg Ojd Pleven Bulgaria
Lsmvg Cqzhoq Srst de Trreht Krolpzyktep de Asinypt Krcvnrfo Szczecin Poland
Wpdyygdp Pgicgq Dzvybtdi Spatxzqcsecmvxalsb I Nablffpbkuwomrm Ooiuhqt Gdynia Poland
Minzkyndc Dsqzzkspykwr Remscheid Germany
Shdvqkdywtglba ah dqr Htqu Goj Bramsche Germany
Uvupfmsipa Hqigftvh Csvzurr Cologne Germany
Ghvatd Udbuogxmph Fctxnfwpq Frankfurt Germany
Czoqch Hkboulqodl Udtdaifdaaaxk Df Pnsun Eoviyn Porto Portugal
Pwabalu Sii z orba Katowice Poland
Dzopzbmxucifah auzrdhxxy Mhbew Pvty Txtdwpl Svitavy Czechia
Kntiv axgunmlje Kxfuy Hmzz sixhpj Hlouska Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
18.02.2025
Bulgaria Bulgaria
Not recruiting
18.02.2025
Czechia Czechia
Not recruiting
18.02.2025
Germany Germany
Not recruiting
18.02.2025
Poland Poland
Not recruiting
18.02.2025
Portugal Portugal
Not recruiting
18.02.2025

Trial locations

Investigated drugs:

ESK-001 is a new medication being tested to see if it can help people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. This medication is being compared to a placebo, which is a substance with no active ingredients, to see if it works better in reducing the symptoms of psoriasis. The study aims to find out if ESK-001 can improve the skin condition of patients more effectively than the placebo over a period of 16 weeks.

Investigated diseases:

Moderate to Severe Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition characterized by the rapid growth of skin cells, leading to the formation of thick, red, scaly patches or plaques on the skin. These plaques often appear on the elbows, knees, scalp, and lower back, but they can occur anywhere on the body. The disease progresses through cycles of flare-ups and remission, where symptoms may improve or worsen over time. During flare-ups, the affected skin can become itchy, painful, and may crack or bleed. The severity of the condition can vary, with moderate to severe cases involving more extensive skin coverage and more intense symptoms. Environmental factors, stress, and certain medications can trigger or exacerbate the condition.

Trial ID:
2023-507193-40-00
Protocol code:
ESK-001-016
NCT ID:
NCT06586112
Trial Phase:
Therapeutic confirmatory (Phase III)

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