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Study on the Effectiveness and Safety of ESK-001 and Apremilast for Patients 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 for Moderate to Severe Plaque Psoriasis, a skin condition that causes red, scaly patches on the skin. The study will test a medication called ESK-001, which is taken as a tablet by mouth. The trial will compare the effects of ESK-001 with a placebo and another medication called Otezla, which contains the active ingredient apremilast.

The purpose of the study is to determine if ESK-001 is more effective than a placebo after 16 weeks of treatment. Participants will be randomly assigned to receive either ESK-001, Otezla, or a placebo. The study will last up to 24 weeks, during which participants will take the medication orally. The trial aims to see improvements in the skin condition by measuring changes in the severity and extent of the psoriasis patches.

Throughout the study, participants will be monitored to assess the safety and effectiveness of the treatments. The trial will help researchers understand if ESK-001 can provide better outcomes for people with moderate to severe plaque psoriasis compared to existing treatments. This study is an important step in finding new and effective ways to manage this chronic skin condition.

1 joining the study

Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will receive either the study medication, a placebo, or an active comparator. The assignment is random, like flipping a coin, and neither you nor the study team will know which group you are in.

2 medication administration

If you are assigned to the group receiving Otezla, you will take film-coated tablets orally. The dosage will be 30 mg, and you will take the medication as directed by the study team.

If you are assigned to the group receiving ESK-001, you will take the tablets orally. The dosage and frequency will be provided by the study team.

If you are assigned to the placebo group, you will take a tablet that looks like the study medication but does not contain the active substance. This is to help understand the effect of the study medication compared to no active treatment.

3 treatment duration

The treatment will last for up to 16 weeks. During this time, you will continue to take the medication as instructed by the study team.

4 regular check-ups

Throughout the study, you will have regular check-ups with the study team. These visits are important to monitor your health and the effects of the treatment.

During these visits, the study team will assess your condition and may perform tests to evaluate the effectiveness and safety of the treatment.

5 end of treatment evaluation

At the end of the 16-week treatment period, you will have a final evaluation. This will include assessments similar to those conducted during the study to determine the overall impact of the treatment.

Who Can Join the Study?

  • Males or females, age 18 years or older.
  • Must have been diagnosed with plaque psoriasis for at least 6 months before the Screening Visit. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
  • Patches of psoriasis must cover at least 10% of the body surface area (BSA) at the Screening Visit and on Day 1 of the study.
  • Must have a PASI score of 12 or higher at the Screening Visit and on Day 1. PASI stands for Psoriasis Area and Severity Index, which measures the severity of psoriasis.
  • Must have a sPGA score of 3 or higher at the Screening Visit and on Day 1. sPGA stands for Static Physician’s Global Assessment, which is a scale used to assess the severity of psoriasis.
  • Women of childbearing potential and males who are sexually active with women of childbearing potential must agree to use highly effective methods of contraception for the entire duration of the study. This is to prevent pregnancy during 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 severe allergic reactions to any of the ingredients in the study medication.
  • Patients who are currently participating in another clinical trial.
  • Patients with any significant medical conditions that could affect their safety or the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with certain types of infections.
  • Patients who have had a recent vaccination.
  • Patients who have a history of cancer, except for certain types of skin cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Centrul Medical Dr. Ianosi Craiova Romania
Smite Aija practice in Dermatology Talsi Latvia
Hautarztpraxis Dr. Gerlach Dresden Germany
Specjalistyczny Gabinet Dermatologiczno- Kosmetyczny Cracow Poland
Cabinet Medical Individual Lauderma Iasi Romania
Studienzentrum Dr. Beate Schwarz Langenau Germany
Evimed Sp. z o.o. Warsaw Poland
Veselibas Centrs 4 SIA Riga Latvia
Futuremeds Sp. z o.o. Wroclaw Poland
CABINET MEDICAL DE DERMATO VENEROLOGIE Prof.Dr. ORASAN R. REMUS IOAN Cluj Napoca Romania
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak Lodz Poland
Innomedica OÜ Tallin Estonia

Other Sites

Site Name City Country Status
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Centre Hospitalier Universitaire Rouen Rouen France
Specderm Poznanska Sp. j. Bialystok Poland
Zanamed Medical Clinic Sp. z o.o. Lublin Poland
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Mtz Clinical Research Powered By Pratia Warsaw Poland
Rcmed Oddzial Sochaczew Sochaczew Poland
Vita Longa Sp. z o.o. Katowice Poland
Rosenpark Research GmbH Darmstadt Germany
Derma-B Kft. Debrecen Hungary
Dr. Niesmann And Dr. Othlinghaus GbR Bochum Germany
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
ISA Interdisciplinary Study Association GmbH Berlin Germany
Tagast 41 Nice France
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
University Of Debrecen Debrecen Hungary
Rigas 1. slimnica SIA Riga Latvia
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Universitaetsklinikum Erlangen AöR Erlangen Germany
Centre Hospitalier Le Mans Le Mans France
Tartu University Hospital Tartu Estonia
Semmelweis University Budapest Hungary
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Pratia S.A. Skorzewo Poland
Klinik Hietzing Vienna Austria
Hopital Prive D Antony Antony France
Hopitaux Drome Nord Romans-Sur-Isere France
Medizinisches Versorgungszentrum DermaKiel GmbH Kiel Germany
Spitalul Clinic Judetean Mures Targu Mures Romania
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Allergo-Derm Bakos Kft. Szolnok Hungary
Klinische Forschung Osnabrueck Osnabrück Germany
Polyclinique Courlancy-Bezannes Reims France
Care Clinic Sp. z o.o. Katowice Poland
DermaMed Research Kft. Oroshaza Hungary
Center for Clinical and Basic Research AS Tallin Estonia
Vital Medical Center Veszprem Hungary
Msbgivbicij Cjpvmmm Fud Mqvgets Sgwydeb &ilil Syewspyw Ghhl Magdeburg Germany
Ornkjmnvcgbdmk Kaelrq ex Fvakhwvll Kkxq Debrecen Hungary
Hbvfilea Ukeaoinsmftiq Db Lu Pdtbnclv Madrid Spain
Cczijvy Minimrm Dz Daeytnlbwz Si Tpftfbrtt Ajhctvmgb Nziuln Sdnnse Brasov Romania
Kyhilgxdj Fhtpgioct Defveiq Ggdc Dresden Germany
Bhc Tjool Mcs Sbemq Bucharest Romania
Vcfdnnua Mjdpyqq Smvbms Craiova Romania
Sdxkkdtmxa Sgw Kuldiga Latvia
Jnountg Szw Riga Latvia
Vrogapwx ug edcexsqj Svr Riga Latvia
Bacntgiabdj Vpuhcfzld Owqopripkibw Kecskemet Hungary
Uwbebaletquxkkjldhryf Dubrszklwmg Aot Duesseldorf Germany
Uwdyzuwgufddsvyfowujr Mznwjpbj Aav Munster Germany
Gotyytudouszofny Zwznwgt Bkpx Bonn Germany
Diatveovge Szw z omvq Wroclaw Poland
Hegughlp Dt Lf Skxuk Clfr I Skep Pvv Barcelona Spain
Fihrtopwn Pnjd Lv Irxjvnsrdcuhi Bhuerlipn Dqn Hytfsbyv Uyzdrhdhcqdqu Lf Paj Madrid Spain
Hqbmxlxl Uhifxwjmrfpkf Hulvoizn Tngin y Pqlsuz Iciksnqf Cglrxq dtepuzwnohzqumvci (gxdu Badalona Spain
Liutisk Sbsfgkoeptedgvm Gzcnhnh Dezfjngxrdtzfra Lublin Poland
Dyqcctmphjan Qyfwg Mainz Germany
Uou Mgltwfj Tqpmyj Kmpm Budapest Hungary

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
06.02.2025
Estonia Estonia
Not recruiting
06.02.2025
France France
Not recruiting
06.02.2025
Germany Germany
Not recruiting
06.02.2025
Hungary Hungary
Not recruiting
06.02.2025
Latvia Latvia
Not recruiting
06.02.2025
Poland Poland
Not recruiting
06.02.2025
Romania Romania
Not recruiting
06.02.2025
Spain Spain
Not recruiting
06.02.2025

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 studied to find out if it works better than a placebo, which is a substance with no active ingredients, over a period of 16 weeks. The goal is to see if ESK-001 can reduce the symptoms of psoriasis and improve the skin condition of the patients participating in the trial.

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 known as plaques. 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. In moderate to severe cases, the plaques cover a larger area of the body and can be more inflamed and itchy. The condition is associated with systemic inflammation, which can also affect other parts of the body. The exact cause of plaque psoriasis is not fully understood, but it involves a combination of genetic and environmental factors.

Trial ID:
2023-508959-39-00
Protocol code:
ESK-001-017
NCT ID:
NCT06588738
Trial Phase:
Therapeutic confirmatory (Phase III)

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