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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
Specjalistyczny Gabinet Dermatologiczno- Kosmetyczny Cracow Poland
CABINET MEDICAL DE DERMATO VENEROLOGIE Prof.Dr. ORASAN R. REMUS IOAN Cluj Napoca Romania
Hautarztpraxis Dr. Gerlach Dresden Germany
Smite Aija practice in Dermatology Talsi Latvia
Centrul Medical Dr. Ianosi Craiova Romania
Cabinet Medical Individual Lauderma Iasi Romania
Innomedica OÜ Tallin Estonia
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
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak Lodz Poland

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Semmelweis University Budapest Hungary
Hospital General Universitario De Valencia Valencia Spain
Hospital Del Mar Barcelona Spain
Klinische Forschung Osnabrueck Osnabrück Germany
Center for Clinical and Basic Research AS Tallin Estonia
Polyclinique Courlancy-Bezannes Reims France
Centre Hospitalier Le Mans Le Mans France
Klinik Hietzing Vienna Austria
Rcmed Oddzial Sochaczew Sochaczew Poland
Vita Longa Sp. z o.o. Katowice Poland
Care Clinic Sp. z o.o. Katowice Poland
Vital Medical Center Veszprem Hungary
Uojcrdvifs Ob Dxdpvhrd Debrecen Hungary
Uxexhxwohfrfeeweehwxr Eyvicwjq Avu Erlangen Germany
Uhcpwqldfdtgethjsyiib Dpvlcommost Aot Duesseldorf Germany
Uhwxfhbcvfip Da Sxykcpju Ds Ceoxoledja Santiago De Compostela Spain
Utavjrzkausmmggqiiwdi Mzgpwowj Anm Munster Germany
Hxhclft Paeqv D Ardytj Antony France
Hnrskvvg Do Lo Slrhm Cxbl I Skks Pob Barcelona Spain
Uhtbxzkoynxxozugufqkf Sivzaspabokrnipepp Agc Kiel Germany
Hrrhathj Umqsbinnadwdy 1z Du Ojrrzsa Madrid Spain
Hmuygend Usruzhlaybhlh Dl Lr Pfgzdubd Madrid Spain
Fbvjsfnwq Pxfb Lh Iyhdkkirwubzc Budzluiwh Dnq Hiykpoqw Usxjukhyzuqff Ly Pjl Madrid Spain
Cpytdzz Moyupfy Ds Dyozqwqfrw Sa Tvjwyatbq Ailrgmfcw Njspeq Sihohg Brasov Romania
Kdvphcy Abscosjdk Sqv z oovi Warsaw Poland
Dppdjsna Rwhmwhcz Krzm Oroshaza Hungary
Krkinxld Orjvhquax Acu Oldenburg In Holstein Germany
Usufcmqrkzzad Slkgllj Koimhvcbu Isajwhvouion Cuftbac W Rfbtfjzum Rzeszow Poland
Blpmbfogvjd Vjqkhvoxy Ojviweytwbvg Kecskemet Hungary
Albcnkhfvjev Beszo Kife Szolnok Hungary
Rxrec 1u szzlhowt Sns Riga Latvia
Kxucbkjubhs Unbuaxiys Kcioud Op Tartu Estonia
Dsllbccqupgy Qabqr Mainz Germany
Sjrvrrff Pzbukjwlw Sku jz Bialystok Poland
Lkbgcaq Skhffxckqlrktcg Gooobam Dcfzrlhsrxxeqrq Lublin Poland
Maadmzwisoc Cuxiwge Flq Mstwgdb Sjzbvfi &gaik Sdmuadrm Gbpf Magdeburg Germany
Owismtaubaqjuj Koejvr ey Fjjipbnsg Kqkt Debrecen Hungary
Zynciog Myippvc Cxsspf Ssf z oizr Lublin Poland
Vpjeopqg Mendhiy Szwrfg Craiova Romania
Jzvpbsl Sgb Riga Latvia
Vdbvvwkq ut ehvpckxk Skm Riga Latvia
Swbofvdxgd Snk Kuldiga Latvia
Boc Tlrwq Msn Slijm Bucharest Romania
Tstpf Uxrgbzsrdx Hzbgijje Tartu Estonia
Gnmcrkeroekcjvpb Zfmmxup Bpxi Bonn Germany
Pwugdw Srbv Skorzewo Poland
Hnlmxqjd Djhhq Nwlm Romans-Sur-Isere France
Mmsfjwspsyzvs Volszqoqgiobowegbu Ducjwznij Gjny Kiel Germany
Sfdwebnz Chsimm Jzcinuna Mnxud Targu Mures Romania
Dapvbytuvf Shn z oest Wroclaw Poland
Hpllyv Kmovkkga Suxurctp Gnus Schwerin Germany
Egay Kzyazznj Snkdebojluobdgf geixv Buxtehude Germany
Mis Crvlkahh Rmmdntfg Popbnho Bw Pgveon Warsaw Poland
Kokffvjuw Fcbluaftk Dkglwcm Gfnw Dresden Germany
Csjapvze Bcal Srvagzafj Sms z odsi Stxw Lublin Poland
Rgawabsmg Ralqtjvw Gsdw Darmstadt Germany
Irq Itizhttiqfhhadggn Sfidx Apgwzsmatmn Gbae Berlin Germany
Dmrxvdr Kscg Debrecen Hungary
Dqh Ncwkxyuu Aih Ddt Otqefotrtrp Gse Bochum Germany
Tmtvki 4t Nice France
Hmiiduqe Uuozwkusxbgax Hnonotjh Thcyn y Piyqsv Ieeksauv Cvrgvn dqjdgwrmmewmcyqcj (hjyn Badalona Spain
Uii Mhbcvwr Tdhcah Kezc 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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