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), a chronic autoimmune disease where the immune system attacks healthy tissues, causing inflammation and damage to various parts of the body. The medication is provided in the form of a film-coated tablet and is taken orally. The study also includes a comparison with a placebo to evaluate the effectiveness and safety of deucravacitinib.

The purpose of the study is to determine if deucravacitinib is more effective than a placebo in treating participants with active SLE. Participants will be randomly assigned to receive either deucravacitinib or a placebo. The study will last for a period of time, during which participants will be monitored for changes in their condition and any side effects. The main goal is to see how many participants achieve a significant improvement in their SLE symptoms after 52 weeks of treatment.

Throughout the study, participants will undergo regular assessments to track their progress and any changes in their health. These assessments will include evaluations of joint involvement, skin conditions, and overall disease activity. The study aims to provide valuable information on the potential benefits and risks of using deucravacitinib for treating SLE, contributing to the understanding of how this medication can help manage the disease.

1 joining the study

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

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

If you are assigned to the deucravacitinib group, you will take a 3 mg tablet once daily by mouth. If you are in the placebo group, you will take a placebo tablet once daily by mouth.

The duration of the medication administration is up to 52 weeks, during which you will continue your regular background therapy for lupus, which may include anti-malarial agents, immunosuppressants, and corticosteroids.

3 regular check-ups

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

You will be asked to report any side effects or changes in your condition to the study team promptly.

4 evaluation of treatment effectiveness

The primary goal of the study is to determine if deucravacitinib is more effective than the placebo in treating systemic lupus erythematosus (SLE). This will be assessed by measuring your response to treatment at week 52.

Secondary evaluations will include improvements in skin symptoms, joint involvement, and overall disease activity, as well as any changes in fatigue levels.

5 completion of the study

At the end of the 52-week period, you will have a final evaluation to assess the overall impact of the treatment on your condition.

You will be informed about the treatment you received during the study, and the study team will discuss any further steps or recommendations for your ongoing care.

Who Can Join the Study?

Participants must be male or female and aged between 18 to 75 years.
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)
Participants must have active lupus, which means:
- A total SLEDAI-2K score of 6 points or more. (SLEDAI-2K is a tool used to measure disease activity in lupus.)
- A clinical SLEDAI-2K score of 4 points or more, which 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. (These are medications used to manage lupus.)
Participants may also be taking corticosteroids. (These are medications that help reduce inflammation.)

Who Cannot Join the Study?

Having an active case of Systemic Lupus Erythematosus (SLE), which is a condition where the immune system attacks the body’s 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
NZOZ LECZNICA MAK-MED s.c.	Nadarzyn	Poland
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland
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Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Hightech Medical Services S.R.L.	Bucharest	Romania
Medisof Diagnostic S.R.L.	Craiova	Romania
Medaudio-Optica S.R.L.	Ramnicu Valcea	Romania
Policlinica CCBR S.R.L.	Bucharest	Romania
Medical Center Excelsior OOD	Sofia	Bulgaria
Spitalul Clinic Colentina Bucuresti	Bucharest	Romania
RK MedCenter SRL	Iasi	Romania
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Medyczne Centrum Hetmanska	Poznan	Poland
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen	Chemnitz	Germany
Universita’ Di Pisa	Pisa	Italy
Ludwig Maximilian University Of Munich	Munich	Germany
Synexus Polska Sp. z o.o.	Poznan	Poland
Pratia S.A.	Skorzewo	Poland
Ko-Med Centra Kliniczne Sp. z o.o.	Zamosc	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Saint Maria Hospital	Bucharest	Romania
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Delta Health Care S.R.L.	Bucharest	Romania
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Banat Carina Med S.R.L.	Timisoara	Romania
Our Ladys Hospital Manorhamilton	Sligo	Ireland
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.	Bialystok	Poland
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Connolly Hospital	Dublin	Ireland
Klinische Forschung Im Medizinischen Versorgungsalltag GbR	Planegg	Germany
Hlnmttkl Slaj	Bucharest	Romania
Asdlcyfq Cdlj Cgyzir Deyxefwqvh Ail Ckkkateoklzr Cvdgak Lzvr	Sofia	Bulgaria
Uyfjgzinju Hbttulmp Cagwedl	Cologne	Germany
Cznoxr Hutlwztkjhb Rrbmeodg Uyfjkzlrsvdrc Dk Tquyr	Tours	France
Cbwo Uupoyfiqwj Hcoyexgs	Cork	Ireland
Cws Kypttcy Bktmgcs	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.05.2023
France	Not recruiting	01.05.2023
Germany	Not recruiting	01.05.2023
Ireland	Not recruiting	01.05.2023
Italy	Not recruiting	01.05.2023
Lithuania	Not recruiting	01.05.2023
Poland	Not recruiting	01.05.2023
Romania	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

Deucravacitinib

Deucravacitinib is a medication being studied for its potential to help people with a condition called systemic lupus erythematosus, or SLE. SLE is an autoimmune disease, which means the body’s immune system mistakenly attacks its own tissues. Deucravacitinib works by targeting specific pathways in the immune system that are involved in inflammation and immune response. By doing this, it aims to reduce the symptoms of SLE, such as joint pain, skin rashes, and fatigue, and improve the overall quality of life for people with this condition. The goal of the trial is to see if deucravacitinib is more effective than a placebo in treating SLE.

Systemic Lupus Erythematosus (SLE) – Systemic Lupus Erythematosus 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 exact cause of SLE is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors.

Trial ID:

2022-500699-76-00

Protocol code:

IM011246

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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