Study on the Effectiveness and Safety of Deucravacitinib for Patients with Active Systemic Lupus Erythematosus (SLE)

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What is this study about?

This clinical trial is focused on studying the effects of a medication called deucravacitinib on individuals with Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease where the immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The medication being tested, deucravacitinib, is taken orally in the form of a film-coated tablet. The study also includes a comparison with a placebo to evaluate the effectiveness and safety of deucravacitinib.

The purpose of this study is to determine if deucravacitinib is more effective than a placebo in treating people with active SLE. Participants in the study will be randomly assigned to receive either deucravacitinib or a placebo. The study will last for a period of 52 weeks, during which participants will be monitored for their response to the treatment. The main goal is to see how many participants achieve a significant improvement in their SLE symptoms by the end of the study period.

Throughout the study, participants will be assessed for changes in their condition, including improvements in joint pain, skin rashes, and overall disease activity. The study will also track any side effects or adverse events that may occur. By the end of the study, researchers hope to gather valuable information on the potential benefits and risks of using deucravacitinib for treating SLE, which could lead to better treatment options for those affected by this condition.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the deucravacitinib 3 mg tablet or a placebo. A placebo is a tablet that looks like the real medication but does not contain the active substance.

The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

2 medication administration

You will take the assigned tablet orally once a day. The duration of the treatment is planned for up to 52 weeks.

It is important to take the medication as directed and not to miss any doses to ensure the study’s accuracy.

3 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. These may include physical exams, blood tests, and other assessments.

These check-ups are crucial to ensure your safety and to gather data on the medication’s effectiveness.

4 reporting symptoms and side effects

You will be asked to report any symptoms or side effects you experience during the study. This information is vital for assessing the safety of the medication.

If you experience any severe side effects, you should inform the study team immediately.

5 completion of the study

At the end of the 52-week period, you will have a final assessment to evaluate the overall effects of the treatment.

The study team will discuss the results with you and provide guidance on any further steps if necessary.

Who Can Join the Study?

  • Participants must be male or female and between 18 to 75 years old.
  • Participants must have been diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening.
  • Participants must meet the 2019 classification criteria for SLE set by the European Alliance of Associations for Rheumatology/American College of Rheumatology.
  • Participants must test positive for at least one of the following lupus-related autoantibodies at the time of screening:
    • Antinuclear antibodies (ANA) with a level of 1:80 or higher
    • Anti-dsDNA antibody
    • Anti-Smith (anti-Sm) antibody
  • Participants must have active lupus, which means:
    • A total SLEDAI-2K score of 6 points or more
    • A clinical SLEDAI-2K score of 4 points or more
    • Must include joint involvement, cutaneous vasculitis (inflammation of blood vessels in the skin), and/or rash
  • Participants must be on stable background therapy with anti-malarial agents and/or immunosuppressants (medications that reduce the activity of the immune system).
  • Participants may also be on corticosteroids (a type of medication that reduces inflammation).

Who Cannot Join the Study?

  • Having an active case of Systemic Lupus Erythematosus (SLE), which is a disease where the immune system attacks its own tissues.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
M2m Med. Sp. z o.o. Chorzow Poland
Pomeranian Medical University Szczecin Poland
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Hospital Universitario Y Politecnico La Fe Valencia Spain
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Hippokration Hospital Athens Greece
General University Hospital Of Larissa Larissa Greece
Reumed Sp. z o.o. Lublin Poland
University Of Pecs Pecs Hungary
Revmatologicky Ustav Prague Czechia
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Synexus Polska Sp. z o.o. Poznan Poland
Pratia S.A. Skorzewo Poland
Somed Cr Sp. z o.o. sp.k. Lodz Poland
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Hospital Universitario Rio Hortega Valladolid Spain
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
Hospital Universitario Basurto Bilbao Spain
Dkc 1 Ruse EOOD Ruse Bulgaria
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Instituto Portugues De Reumatologia Lisbon Portugal
Centrum Medyczne Oporow Wroclaw Poland
Ambulatorium Sp. z o.o. Elblag Poland
Hospital De Merida Merida Spain
University Of Szeged Szeged Hungary
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny Im Wiktora Degi Uniwersytetu Medycznego Im Karola Marcinkowskiego W Poznaniu Poznan Poland
Vital-Medicina Kft. Veszprem Hungary
Inrea s.r.o. Ostrava Czechia
Mzhztkroj Ikkaamksbv Comtlvdb Svejhbjk Sws z ogtb Warsaw Poland
Lutyz Gofmjdf Hjpbilak Oz Awocnw Athens Greece
Hccnssjm Uoouvatnicrya Mgllmdf Dm Vkackwbolh Santander Spain
Hzfxczyq Vzhs dommlkns Barcelona Spain

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
01.05.2023
Czechia Czechia
Not recruiting
01.05.2023
Greece Greece
Recruiting
01.05.2023
Hungary Hungary
Not recruiting
01.05.2023
Poland Poland
Not recruiting
01.05.2023
Portugal Portugal
Not recruiting
01.05.2023
Spain Spain
Not recruiting
01.05.2023

Trial locations

Investigated drugs:

Deucravacitinib is a medication being studied for its potential to help people with a condition called systemic lupus erythematosus, or SLE for short. SLE is an autoimmune disease, which means the body’s immune system mistakenly attacks its own tissues. This can cause inflammation and damage in different parts of the body. Deucravacitinib works by targeting specific pathways in the immune system to reduce this inflammation and help control the symptoms of SLE. The goal of using deucravacitinib in this study is to see if it can be more effective than a placebo in improving the condition of people with SLE.

Investigated diseases:

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. Over time, SLE can lead to inflammation and damage in the affected organs. The progression of the disease can vary greatly among individuals, with periods of flares and remissions. The severity and specific symptoms can change over time, making it a complex condition to manage.

Trial ID:
2022-500700-22-00
Protocol code:
IM011247
Trial Phase:
Therapeutic confirmatory (Phase III)

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