Study on the Effectiveness and Safety of Deucravacitinib for Adults with Active Sjogren’s Syndrome

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What is this study about?

This clinical trial is focused on studying the effects of a medication called deucravacitinib in adults with a condition known as Sjögren’s syndrome. Sjögren’s syndrome is an autoimmune disease, which means the body’s immune system mistakenly attacks its own cells, leading to symptoms like dry eyes and mouth. The study will use deucravacitinib in two different doses, 3 mg and 6 mg, in the form of film-coated tablets taken orally. Some participants will receive a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how effective and safe deucravacitinib is for treating active Sjögren’s syndrome. Participants will be randomly assigned to receive either the medication or a placebo. The study will last for about a year, during which participants will have regular check-ups to monitor their health and any changes in their symptoms. The main goal is to see if there is an improvement in the disease activity after 52 weeks of treatment.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The study aims to provide valuable information on whether deucravacitinib can be a beneficial treatment option for people with Sjögren’s syndrome. This research could potentially lead to new ways to manage the symptoms and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, participants will be randomly assigned to receive either the medication deucravacitinib or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo.

2 medication administration

Participants will take the assigned medication orally. The options include deucravacitinib in doses of 3 mg or 6 mg, or a placebo, all in the form of film-coated tablets.

The medication will be taken as prescribed by the study protocol, which will specify the exact dosage and frequency.

3 monitoring and assessments

Throughout the study, participants will undergo regular assessments to monitor the effectiveness and safety of the treatment. These assessments will include measuring changes in the ESSDAI (a disease activity index for Sjögren’s syndrome) at various intervals, including Week 24 and Week 52.

Additional assessments will evaluate changes in symptoms such as fatigue, dryness, and joint/muscle pain, as well as any side effects or adverse events.

4 completion of the study

The study is expected to last until November 2028, with the primary objective being the comparison of the efficacy of deucravacitinib versus placebo by measuring improvements in the ESSDAI at Week 52.

Upon completion, participants will have contributed valuable data to help understand the potential benefits and risks of deucravacitinib for treating active Sjögren’s syndrome.

Who Can Join the Study?

  • Participants must be adults, which means they should be at least 18 years old or the age considered an adult in their country.
  • Participants need to meet the 2016 criteria set by the American College of Rheumatology and the European League Against Rheumatism for a condition called Sjogren’s syndrome.
  • Participants should have moderate to severe Sjogren’s syndrome, which is measured by a score called ESSDAI that should be 5 or higher.
  • Participants must test positive for a specific antibody known as anti-SSA/Ro antibody.
  • The condition should have been present for a short time, meaning 10 years or less.
  • Participants need to have a salivary flow rate of at least 0.05 mL per minute. This measures how much saliva is produced.

Who Cannot Join the Study?

  • Participants who have any other serious health condition that could interfere with the study.
  • Individuals who are currently pregnant or breastfeeding.
  • People who have had a recent infection that required treatment with antibiotics or antiviral medications.
  • Participants who have received any other investigational drug within a certain period before the study.
  • Individuals with a history of allergic reactions to similar medications.
  • People who have been diagnosed with cancer within the last five years, except for certain types of skin cancer.
  • Participants who have a history of drug or alcohol abuse.
  • Individuals who have received a live vaccine within a certain period before the study.
  • People who have a history of certain blood disorders.
  • Participants who have had a major surgery within a certain period before the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o Wroclaw Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
General University Hospital Of Larissa Larissa Greece
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hospital Universitario De Canarias La Laguna Spain
University Of Debrecen Debrecen Hungary
Med Polonia Sp. z o.o. Poznan Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universita’ Campus Bio-medico Di Roma Rome Italy
Turku University Hospital Turku Finland
Universita’ Di Pisa Pisa Italy
Ludwig Maximilian University Of Munich Munich Germany
Assistance Publique Hopitaux De Paris Paris France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Satucon Oy Kuopio Finland
Universitair Ziekenhuis Gent Gent Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Charite Research Organisation GmbH Berlin Germany
Hospital De Santa Maria E.P.E. Lisbon Portugal
Universita Degli Studi Di Brescia Brescia Italy
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Region Stockholm – SLSO Stockholm Sweden
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Instituto Portugues De Reumatologia Lisbon Portugal
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Hospital De Merida Merida Spain
Rheuma Medicus Sp. z o.o. Warsaw Poland
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej Wroclaw Poland
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Mkjkxcfqe Iqpsmeaacz Cfwgmlsd Snbcfxcd Spn z owjw Warsaw Poland
Anmrmuz Ctwxtfc Srjnib Bucharest Romania
Lxkpq Geyhfkf Hatplqnz Oe Abrfxl Athens Greece
Gqnctw Hqjctuqhrmg Dg Hmkzd Le Havre France
Axoxnvwjyh Pjfxkxvh Hfpnnyir De Pioow Paris France
Exn Lldsib Lublin Poland
Hruremva Ubuhzmieyy Ckxrodr Hblzjmqs Helsinki Finland
Ezlrqhc Uoxetktvlvnz Mkctydy Cmiqzss Rkqqhdbiw (lehqtwy Mlw Rotterdam The Netherlands
Ssvsmolkyen Uijvbzqeaj Hqiozmvehlmjqkt Ggtzydczwjvhwuoar Gothenburg Sweden
Ulcqzuusfooaalyfwllok Wewndcqie Aag Wuerzburg Germany
Utklvzigghbf Mpncbhm Cvymsjq Gupqakfds Groningen The Netherlands
Hsbbllty Ukcfnidbgfrwr Mlxrfmo Do Vkrzcimksi Santander Spain
Chokbjx Mlmftco Dr Dffmmimtzw Sa Tetngdarx Aihdprpxn Ngjdlm Skbqos Brasov Romania
Hxlqewfl Uqosxtffmsvwt dd A Cqqnvj A Coruna Galicia Spain
Cig Khsljpv Bzftguw Le Kremlin-Bicetre France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
10.01.2024
Belgium Belgium
Recruiting
10.01.2024
Bulgaria Bulgaria
Recruiting
10.01.2024
Finland Finland
Recruiting
10.01.2024
France France
Recruiting
10.01.2024
Germany Germany
Recruiting
10.01.2024
Greece Greece
Recruiting
10.01.2024
Hungary Hungary
Recruiting
10.01.2024
Italy Italy
Recruiting
10.01.2024
Poland Poland
Recruiting
10.01.2024
Portugal Portugal
Recruiting
10.01.2024
Romania Romania
Recruiting
10.01.2024
Spain Spain
Recruiting
10.01.2024
Sweden Sweden
Recruiting
10.01.2024
The Netherlands The Netherlands
Recruiting
10.01.2024

Trial locations

Investigated drugs:

Deucravacitinib is a medication being studied for its potential to help people with active Sjögren’s Syndrome. This condition is an autoimmune disorder that primarily affects the glands that produce tears and saliva, leading to dry mouth and eyes. The trial aims to see if this medication can improve symptoms by reducing inflammation and other related issues.

Investigated diseases:

Sjogren’s syndrome – Sjogren’s syndrome is an autoimmune disorder characterized by the body’s immune system mistakenly attacking its own moisture-producing glands. This leads to symptoms such as dry eyes and dry mouth, as the glands responsible for producing tears and saliva are affected. Over time, the condition can also impact other parts of the body, including the joints, skin, and organs like the kidneys and liver. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe complications. It is a chronic condition, meaning it persists over a long period, and symptoms can fluctuate in intensity. The exact cause of Sjogren’s syndrome is not fully understood, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:
2023-503327-26-00
Protocol code:
IM011-1069
NCT ID:
NCT05946941
Trial Phase:
Therapeutic confirmatory (Phase III)

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