#1 Clinical Trials Search in Europe

Study on Deucravacitinib and Apremilast for Patients with Active Psoriatic Arthritis New to Biologic Treatments or Previously on TNFα Inhibitors

3 1 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called deucravacitinib on individuals with Psoriatic Arthritis, a condition that causes joint pain and swelling along with skin symptoms. The study will compare the effectiveness and safety of deucravacitinib with a placebo. Participants in the study may have never used biologic treatments for their condition or may have previously been treated with medications known as TNFα inhibitors.

The purpose of the study is to evaluate how well deucravacitinib works in treating active psoriatic arthritis. Participants will receive either deucravacitinib or a placebo, and the study will monitor their progress over a period of time. The medication is taken orally in the form of film-coated tablets. The study will assess various health outcomes, including improvements in joint pain and skin symptoms, over several weeks.

Throughout the study, participants will be regularly checked to see how their condition is responding to the treatment. The study aims to provide valuable information on whether deucravacitinib can be an effective treatment option for people with psoriatic arthritis, potentially offering relief from the symptoms associated with this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of psoriatic arthritis (PsA) for at least 3 months.

The assessment includes meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) and checking for active plaque psoriatic skin lesions or a documented history of plaque psoriasis.

Active arthritis is confirmed by the presence of at least 3 swollen joints and 3 tender joints, along with a high sensitivity C-reactive protein (hsCRP) level of 3 mg/L or higher.

2 randomization and treatment allocation

Participants are randomly assigned to receive either deucravacitinib 6 mg tablets or a placebo, both taken orally.

The treatment is administered in a double-blind manner, meaning neither the participant nor the study team knows which treatment is being given.

3 treatment phase

The treatment phase involves taking the assigned medication daily.

Participants are monitored regularly to assess the efficacy and safety of the treatment.

4 evaluation of primary and secondary outcomes

The primary outcome is the proportion of participants achieving a 20% improvement in symptoms, as defined by the American College of Rheumatology (ACR20).

Secondary outcomes include changes in disease activity scores, physical function, and quality of life measures at Week 16.

5 end of study procedures

At the end of the study, participants undergo final assessments to evaluate the overall impact of the treatment.

The study is estimated to conclude by November 3, 2026.

Who Can Join the Study?

  • The patient must have been diagnosed with psoriatic arthritis for at least 3 months before the screening. Psoriatic arthritis is a type of arthritis that affects some people with the skin condition psoriasis.
  • The patient must meet the CASPAR criteria for psoriatic arthritis at the time of screening. CASPAR criteria are a set of guidelines used to diagnose psoriatic arthritis.
  • The patient must have active plaque psoriasis skin lesions or a documented medical history of plaque psoriasis at the time of screening. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
  • The patient must have active arthritis, which means having at least 3 swollen joints and at least 3 tender joints at the time of screening and on the first day of the study.
  • The patient must have a high level of C-reactive protein (hsCRP) in their blood, which is 3 mg/L or higher at the time of screening. C-reactive protein is a substance produced by the liver in response to inflammation.
  • The study is open to both male and female participants.
  • The study includes participants from vulnerable populations, which means it may include people who are at a higher risk of harm or exploitation.

Who Cannot Join the Study?

  • Having any other active disease that affects the immune system, which is the body’s defense system against illnesses.
  • Currently having a serious infection, which is an illness caused by harmful germs like bacteria or viruses.
  • Having a history of cancer, which is a disease where cells in the body grow uncontrollably.
  • Being pregnant or breastfeeding, as the study may affect the baby.
  • Using certain medications that might interfere with the study treatment.
  • Having a history of drug or alcohol abuse, which means using substances in a harmful way.
  • Having a known allergy to the study medication or its ingredients.
  • Participating in another clinical trial at the same time.
  • Having a condition that the study doctors believe would make it unsafe to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Vasarhelyi Sarkanyfu Kft. Hodmezovasarhely Hungary
Futuremeds Sp. z o.o. Wroclaw Poland
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Johannes Wesling Klinikum Minden Minden Germany
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Medical Plus s.r.o. Uherske Hradiste Czechia
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Rheumazentrum Ratingen Ratingen Germany
Vital-Medicina Kft. Veszprem Hungary
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Ciayggzez Uhynkjqvbqasqq Slzinkyug Woluwe-Saint-Lambert Belgium
Hvrukmjc Uvwxymyawuxla Mvwnauv Dh Vypcsdajge Santander Spain
Caqyoyr Bhein Kusbjjnbbpl Pzfiqwjg Spn z opmz Gdansk Poland
Rkbhozktujlq svytan Brno-Sever Czechia
Msof Cjpegfd Mrrqkblz Temhf Torun Poland
Crzlprgfocoeuqb Mngjpd Dss Bhzhc Icrnwe Ketcxz Szentes Hungary
Vkywarsb sbjmoj Moravska Ostrava A Privoz Czechia
Hcjicnpm Vwlm dqfrdesb Barcelona Spain

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
31.08.2021
Czechia Czechia
Not recruiting
31.08.2021
Germany Germany
Not recruiting
31.08.2021
Hungary Hungary
Not recruiting
31.08.2021
Poland Poland
Not recruiting
31.08.2021
Spain Spain
Not recruiting
31.08.2021

Trial locations

Investigated drugs:

Deucravacitinib is a medication being studied for its effectiveness and safety in treating people with active psoriatic arthritis. It is designed to help reduce inflammation and improve symptoms in patients who have not previously used biologic treatments or have used TNFα inhibitors.

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It is associated with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may worsen over time. It often affects the fingers and toes, leading to a sausage-like appearance known as dactylitis. Enthesitis, or inflammation where tendons and ligaments attach to bone, is also common. The progression of psoriatic arthritis can vary, with periods of increased symptoms followed by times of remission.

Trial ID:
2023-506257-37-00
Protocol code:
IM011-055
NCT ID:
NCT04908189
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Tulisokibart for Psoriatic Arthritis in Adults

    Recruiting

    2 1
    Investigated drugs:
    Germany Poland Spain

  • A study to evaluate the effectiveness and safety of JNJ-88545223 in people with active psoriatic arthritis

    Recruiting

    2 1
    Czechia Germany Hungary Poland Spain