Study on Long-Term Safety and Efficacy of Deucravacitinib 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 long-term safety and effectiveness of a medication called deucravacitinib in individuals with moderate-to-severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The study involves taking deucravacitinib, which is provided in the form of a film-coated tablet, and aims to understand how safe and tolerable it is for long-term use in treating this condition.

Participants in the study will receive deucravacitinib, and some may receive a placebo to compare the effects. The study is designed to observe any side effects or adverse events that may occur over time. The goal is to gather information on how well the medication works and how safe it is for people with moderate-to-severe plaque psoriasis.

The study will be conducted over a period of time, allowing researchers to collect data on the medication’s impact on the skin condition. Participants will be monitored for any changes in their condition and any potential side effects. This information will help in understanding the long-term benefits and risks of using deucravacitinib for treating plaque psoriasis.

1 joining the study

Participation begins after completing the required treatment period in a previous study of BMS-986165 for moderate-to-severe plaque psoriasis.

Eligibility requires the ability to sign an informed consent form and, for women, a negative pregnancy test 24 hours before starting the study medication.

2 medication administration

The study involves taking a medication called deucravacitinib, which is provided in the form of a film-coated tablet.

The medication is taken orally. The specific dosage and frequency are determined by the study protocol.

3 monitoring and assessments

Throughout the study, regular assessments are conducted to monitor safety and effectiveness.

Primary focus is on identifying any adverse events or serious adverse events that may occur.

4 evaluation of treatment response

Secondary evaluations include measuring the response of the skin condition using criteria such as sPGA 0/1 response and PASI 75 response.

5 completion of the study

The study is estimated to conclude by August 7, 2026, with ongoing assessments until that date.

Who Can Join the Study?

  • Must have completed the required treatment period in a related study of BMS-986165 for moderate-to-severe plaque psoriasis. This is a skin condition that causes red, scaly patches.
  • Must be willing to participate in the study and able to sign the informed consent form. This means you agree to take part in the study and understand what it involves.
  • Women must not be pregnant, breastfeeding, or planning to become pregnant during the study. A negative urine pregnancy test is required 24 hours before starting the study medication.

Who Cannot Join the Study?

  • Patients with other skin conditions that might interfere with the study.
  • Patients who have had a recent infection that required treatment.
  • Patients with a history of certain types of cancer.
  • Patients who are pregnant or breastfeeding.
  • Patients who have used certain medications recently that could affect the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients with certain heart conditions.
  • Patients with liver or kidney problems.
  • Patients who have participated in another clinical trial recently.
  • Patients with a known allergy to the study medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
SYNEXUS Magyarorszag Kft. Budapest Hungary
Lukmed 2 Sp. z o.o. Siedlce Poland
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Qualiclinic Kft. Budapest Hungary
Solumed Sp. z o.o. sp.k. Poznan Poland
Centrum Medyczne Oporow Wroclaw Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Clinical Research Group Sp. z o.o. Warsaw Poland
ProbarE i Lund AB Lund Sweden
Dr. Niesmann And Dr. Othlinghaus GbR Bochum Germany
Klinika Ambroziak Sp. z o.o. Warsaw Poland
INTER CLINIC Piotr Adrian Klimiuk Bialystok Poland
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o. Iwonicz-Zdroj Poland
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
CentroDerm GmbH Wuppertal Germany
Etg Neuroscience Sp. z o.o. Warsaw Poland
University Of Debrecen Debrecen Hungary
Clintrial s.r.o. Prague Czechia
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Clinmedica Research sp. z o.o. Skierniewice Poland
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Hospital Universitario De Cruces Barakaldo Spain
Centre De Pharmacologie Clinique Appliquee A La Dermatologie Nice France
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Mcm Polimedica 2 Sp. z o.o. Warsaw Poland
Synexus Polska Sp. z o.o. Poznan Poland
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Pratia S.A. Skorzewo Poland
Medizinisches Versorgungszentrum DermaKiel GmbH Kiel Germany
Krajska zdravotni a.s. Teplice Czechia
Pécsi Tudományegyetem Klinikai Központ Pecs Hungary
Allergo-Derm Bakos Kft. Szolnok Hungary
Hautarztpraxis Dr. Wilfried Steinborn Straubing Germany
University Hospital Ostrava Ostrava Czechia
Synexus Clinical Research GmbH Frankfurt Germany
Hospital Universitario Virgen De La Victoria Malaga Spain
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
Suomen Terveystalo Oy Tampere Finland
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Ptetvg Fvqd Djrngviqperh Ujc Vfzpsxejhry Dresden Germany
Nkxbuikyrntk Zywxlj Odaige Zqtsgejbgd Mgvcyihqw Lublin Poland
Dgpcxsrr sinosm Povel Czechia
Mfghuuqkt Icstzfnkvj Cedghtbq Slctxasa Swd z oigg Warsaw Poland
Ncthiseqqacj Ziukkc Oiqxtw Zmdjdkiee Akovryo Cfcdzmm Mfkunqcy Lodz Poland
Lncthnss Av Boras Sweden
Dekzfaviix Snz z oujy Wroclaw Poland
Htixkbjr Uhpscqhweewhg Hhfwhdfi Tpirr y Phzhvi Icdfwjsj Czrlgo dgfttsphohtsfxaqj (evzo Badalona Spain
Mhgdwpj Siaailu Znibfcban w Owmxvtsue Olsztyn Poland

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
02.01.2020
Finland Finland
Not recruiting
02.01.2020
France France
Not recruiting
02.01.2020
Germany Germany
Not recruiting
02.01.2020
Hungary Hungary
Not recruiting
02.01.2020
Poland Poland
Not recruiting
02.01.2020
Spain Spain
Not recruiting
02.01.2020
Sweden Sweden
Not recruiting
02.01.2020

Trial locations

Investigated drugs:

BMS-986165 is a medication being studied for its long-term safety and effectiveness in treating moderate-to-severe plaque psoriasis. This medication is part of a clinical trial to understand how well it works and how safe it is for patients to use over an extended period.

Moderate-to-Severe Plaque Psoriasis – This is a chronic skin condition characterized by the development of thick, red patches covered with silvery-white scales. These patches, known as plaques, can appear anywhere on the body but are most commonly found on the elbows, knees, scalp, and lower back. The disease progresses through cycles, with periods of flare-ups followed by times of remission. During flare-ups, the plaques can become itchy, painful, and may crack or bleed. The severity of the condition can vary, with moderate-to-severe cases involving larger areas of the body and more intense symptoms. The exact cause is not fully understood, but it is believed to involve an immune system dysfunction.

Trial ID:
2022-502361-15-00
Protocol code:
IM011-075
NCT ID:
NCT04036435
Trial Phase:
Therapeutic confirmatory (Phase III)

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