Study of GLPG3667 for Adults with Active Systemic Lupus Erythematosus

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Systemic Lupus Erythematosus (SLE), a disease where the immune system mistakenly attacks healthy tissues in the body, causing inflammation and damage to various organs. The treatment being tested is called GLPG3667, which is taken as a capsule. The study will compare the effects of GLPG3667 to a placebo, which looks like the treatment but does not contain the active ingredient.

The purpose of the study is to evaluate how well GLPG3667 works in reducing the activity of SLE and to assess its safety and tolerability. Participants in the study will receive either GLPG3667 or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will last for several weeks, during which participants will take the medication orally and attend regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, researchers will collect information on how the treatment affects the symptoms of SLE, such as joint pain and skin rashes, and will also monitor for any side effects. The study aims to determine if GLPG3667 can help manage the symptoms of SLE and improve the quality of life for those affected by this condition. Participants will be closely monitored to ensure their safety and well-being throughout the trial.

Who Can Join the Study?

Both men and women can participate if they are between 18 and 75 years old on the day they sign the consent form.
Participants must have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE), which is a long-term disease where the immune system attacks the body’s own tissues, and this diagnosis must have been made at least 24 weeks before the study begins.
The disease must be currently active, measured by a specific scoring system called SLEDAI-2K. To qualify, a person must have a total score of at least 6 points and a clinical score (based on physical symptoms rather than lab tests) of at least 4 points.
Certain symptoms, such as lupus headaches, alopecia (hair loss), organic brain syndrome (changes in mental function), and mucous membrane ulceration (sores in the mouth or nose), will not be used to reach the required score.
Laboratory tests must show a positive result for at least one of the following: antinuclear antibodies (ANA), which are proteins that attack cell nuclei; anti-dsDNA, which are specific antibodies found in lupus; or anti-Smith (anti-Sm) antibodies.
Participants must show signs of the disease in specific areas, such as the mucocutaneous system (skin and mucous membranes) or the musculoskeletal system (joints and muscles) due to arthritis (joint swelling and pain), based on a specialized rating scale called BILAG.
Participants must have been taking at least one type of background therapy for at least 12 weeks before the study, and this medication must stay at the same dose throughout the trial. This includes either one immunosuppressant (a medicine that lowers the immune system’s activity) or one antimalarial (a medicine often used to treat lupus symptoms).
The use of corticosteroids (such as prednisone, which reduces inflammation) or NSAIDs (non-steroidal anti-inflammatory drugs, which are medicines used to reduce pain and swelling) is allowed, but these must have been taken at a stable dose for at least 2 weeks before the study begins.

Who Cannot Join the Study?

People with severe lupus nephritis, which is a serious inflammation of the kidneys caused by lupus, that requires treatment with cytotoxic agents (medicines that kill rapidly dividing cells) or high doses of corticosteroids (strong anti-inflammatory drugs).
People with kidney disease that is not well-controlled, unless the disease is stable with specific protein levels in the urine as measured by a urine protein: creatinine ratio (UPCR).
People with poorly controlled long-term problems with the heart, lungs, or kidneys.
People with severe renal impairment, which means the kidneys are not working well enough, specifically an estimated glomerular filtration rate (eGFR) of less than 30 mL/minute/1.73 m2.
People who have previously used tyrosine kinase 2 (TYK2) inhibitors, which are a specific type of medication.
Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
People who have used prohibited therapies (medicines not allowed in this study) within the required washout period (the time needed for a drug to leave your system).
People with a history of catastrophic antiphospholipid syndrome, a serious condition that causes blood clots, such as a pulmonary embolism (blood clot in the lung), stroke, or deep vein thrombosis (blood clot in a deep vein), or those with multiple unexplained pregnancy losses.
People with active or unstable lupus neuropsychiatric manifestations, which are brain or nerve-related symptoms caused by lupus, though some specific nerve issues like polyneuropathy are allowed.
People whose lupus was caused by a specific medication, known as drug-induced systemic lupus erythematosus.
People with a chronic hepatitis B virus (HBV) infection, which is a virus that attacks the liver.
People with a chronic hepatitis C virus (HCV) infection, which is another virus that can cause liver disease.
People with a history of or current immunosuppressive condition (a condition where the immune system is weakened) or a history of opportunistic infections, which are infections that happen more easily in people with weak immune systems, such as HIV.
People who test positive for SARS-CoV-2 (the virus that causes COVID-19) through an antigen test or a RT-PCR test (a highly sensitive laboratory test used to detect viral genetic material).
People with a history of active tuberculosis (TB) or those who test positive on a QuantiFERON-TB Gold Plus test (a blood test used to check for TB infection).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Praxis für Rheumatologie, Gastroenterologie und Innere Medizin	Munich	Germany
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Futuremeds Sp. z o.o.	Wroclaw	Poland

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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Hospital Universitario Virgen De Valme	Sevilla	Spain
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Hospital De Merida	Merida	Spain
Medical Center Excelsior OOD	Sofia	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz	Bytom	Poland
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Ludwig Maximilian University Of Munich	Munich	Germany
Hospital Universitario Araba	Vitoria	Spain
Synexus Polska Sp. z o.o.	Poznan	Poland
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Barmherzige Brueder Trier gGmbH	Trier	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Reumed Sp. z o.o.	Lublin	Poland
Qualiclinic Kft.	Budapest	Hungary
Vital Medical Center	Veszprem	Hungary
Pghuxaqb Pwztzgmq Labkdrcu Pafe Di Hbc Mcn Pepcj Huhdxj	Poznan	Poland
Thvarcxq Sik z ovos	Piotrkow Trybunalski	Poland
Ubtrkltxdmotodlpxlskc Dxonzavsfho Azo	Duesseldorf	Germany
Hfabmdqn Uxkjdkqjcnwiol Swwbfkvjad &bssedj Hxweosu dm Huzijbizqnz	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.01.2024
France	Not recruiting	01.01.2024
Germany	Not recruiting	01.01.2024
Hungary	Not recruiting	01.01.2024
Poland	Not recruiting	01.01.2024
Spain	Not recruiting	01.01.2024

Trial locations

Investigated drugs:

Glpg3667 Fumarate

GLPG3667 is an experimental medication taken by mouth in capsule form. It is being studied to see if it can help reduce disease activity in adults who have active systemic lupus erythematosus, an autoimmune condition.

Investigated diseases:

Systemic lupus erythematosus

Systemic Lupus Erythematosus – This is a condition where the body’s immune system mistakenly attacks healthy tissues and organs. It can affect many different parts of the body, including the skin, joints, kidneys, blood cells, brain, heart, and lungs. The disease often progresses through periods of high activity followed by periods of relative calm. During active phases, inflammation can cause damage to various organ systems. Skin rashes and joint swelling are common signs as the condition moves forward.

Trial ID:

2023-503183-16-00

Protocol code:

GLPG3667-CL-215

NCT ID:

NCT05856448

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of GLPG3667 for Adults with Active Systemic Lupus Erythematosus

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