A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus
NCT ID: NCT05856448
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
186 participants
INTERVENTIONAL
2023-06-28
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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GLPG3667 - Treatment A
Participant will receive a dose A of GLPG3667 capsules orally once daily (q.d.) for 48 weeks.
GLPG3667
Capsule
GLPG3667 - Treatment B
Participant will receive a dose B of GLPG3667 capsules orally (q.d.) for 48 weeks.
GLPG3667
Capsule
Placebo
Participant will receive placebo matched to GLPG3667 capsules orally q.d for 48 weeks.
Placebo
Capsule
Interventions
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GLPG3667
Capsule
Placebo
Capsule
Eligibility Criteria
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Inclusion Criteria
2. Participant has a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and a clinical SLEDAI-2K score ≥4 at screening and baseline (scores must be confirmed by central review at screening).
* Lupus headache, alopecia, organic brain syndrome, and mucous membrane ulceration will not count toward the score required for screening at entry.
* Clinical SLEDAI-2K excludes laboratory abnormalities such as hematuria, pyuria, urinary casts, proteinuria, positive anti-double-stranded deoxyribonucleic acid (anti-dsDNA), decreased complement, thrombocytopenia, and leukopenia.
3. Participant is positive for 1 of the following: antinuclear antibodies (ANA) ≥1:80 or positive anti-dsDNA (indeterminate values are considered positive), or positive anti-Smith (anti-Sm), as determined by the central laboratory.
4. At least 1 of the following BILAG-based protocol-specific manifestations of SLE:
* BILAG A or B score in the mucocutaneous body system.
* BILAG A or B score in the musculoskeletal body system due to arthritis.
* If only 1 B and no A score is present in the mucocutaneous body system or in the musculoskeletal body system due to arthritis, then at least 1 B score must be present in one of the other body systems, for a total of \>=2 BILAG B body system scores.
5. Background therapy with at least 1 of the following medications is required for \>=12 weeks before the screening visit and must remain stable until randomization and throughout study participation:
* 1 immunosuppressant (combination of immunosuppressants is not permitted), stable at least 8 weeks prior to screening.
* 1 antimalarial, stable at least 8 weeks prior to screening. In addition, oral corticosteroids (CS) (prednisone or equivalent) and/or NSAIDs background therapy is permitted but not required:
* CS (prednisone or equivalent; \<=30 mg/day; CS monotherapy is not permitted), stable at least 2 weeks prior to screening; AND/OR
* Non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs monotherapy is not permitted), stable at least 2 weeks prior to screening.
Exclusion Criteria
2. Participants with pre-existing, controlled renal disease with serum creatinine≥ 2 x upper limit of normal (ULN) and either residual proteinuria up to 3 grams/day (g/day) or a urine protein: creatinine ratio (UPCR) of up to 3 milligrams/milligrams (mg/mg) or 339 milligrams of albumin per millimole of creatinine (mg/mmol) are allowed. Control of renal disease must be documented with at least 2 measurements of proteinuria or UPCR over the past 6 months.
3. Participants with a history of catastrophic antiphospholipid syndrome are excluded. This includes Participants with a serious thrombotic event (e.g. pulmonary embolism, stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit or history of 3 or more unexplained consecutive pregnancy losses. Participants with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose are allowed.
4. Participants with active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria are excluded, with the exception of participants with mononeuritis multiplex and polyneuropathy, who are allowed.
5. Drug-induced SLE.
6. Participant has a chronic hepatitis B virus (HBV) infection, as defined by positive HBV surface antigen (HBsAg) at screening and detectable HBV core antibody (HBcAb).
7. Participant has chronic hepatitis C virus (HCV) infection, as defined by positive HCV antibody (Ab) at screening and detectable HCV viremia. Participants with positive HCV Ab must undergo reflex HCV ribonucleic acid (RNA) testing, and Participants with HCV RNA positivity will be excluded. Participants with positive HCV Ab and negative HCV RNA are eligible.
8. Participant has a history of or a current immunosuppressive condition or a history of opportunistic infections (e.g. human immunodeficiency virus \[HIV\] infection, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis, herpes simplex, herpes zoster).
9. Participant testing positive for severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) infection, even if fully vaccinated against SARS-CoV-2, as detected by rapid antigen testing and/or revert transcription polymerase chain reaction (RT-PCR), test at screening and/or baseline (Day 1). Participant presenting any signs or symptoms suggestive of SARS-CoV-2 infection, as detected at screening or baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnoea, myalgia, anosmia, dysgeusia, anorexia, sore throat), should undergo testing even if fully vaccinated against SARS-CoV-2, as per locally applicable standard diagnostic criteria to diagnose SARS-CoV-2 infection and excluded if positive.
10. Participant meets 1 of the following tuberculosis (TB) criteria at screening:
* A history of active or currently active TB (regardless of treatment).
* A positive QuantiFERON®-TB Gold Plus In-tube test at screening unless the investigator assesses this is due to a documented history of adequately treated latent TB infection.
Note: If the test result is indeterminate, it may be repeated once; if indeterminate or positive on retest, Participant is not eligible.
11. Participant with poorly controlled chronic cardiac, pulmonary, or renal disease.
12. Participant has at screening, presence of severe renal impairment (defined as estimated glomerular filtration rate \[eGFR\] \<30 mL/minute/1.73 m2, using the Chronic Kidney Disease Epidemiology equation).
13. Prior exposure to tyrosine kinase 2 (TYK2) inhibitors.
14. Female participant is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.
15. Participant has taken any prohibited therapies within the defined washout periods before screening, and during screening.
18 Years
75 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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University of Arizona College of Medicine - Tucson
Tucson, Arizona, United States
University of California San Diego
La Jolla, California, United States
Desert Medical Advances
Rancho Mirage, California, United States
Millennium Clinical Trials
Simi Valley, California, United States
Inland Rheumatology Clinical Trials
Upland, California, United States
Upland Rheumatology Center
Upland, California, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
Omega Research DeBary
DeBary, Florida, United States
Alloy Clinical Research, LLC
Kissimmee, Florida, United States
San Marcus Research Clinic
Miami, Florida, United States
Advanced Pharma - Miami
Miami, Florida, United States
Professional Research Center
Miami, Florida, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States
Alliance Clinical Research of Tampa
Tampa, Florida, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Lynn Institute of Tulsa
Tulsa, Oklahoma, United States
New Phase Research & Development
Knoxville, Tennessee, United States
Office of Ramesh C. Gupta MD / Shelby Research LLC - Tennessee
Memphis, Tennessee, United States
Care and Cure Clinic
Houston, Texas, United States
Southwest Arthritis
Mesquite, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Clinica Adventista Belgrano
Belgrano, , Argentina
Maffei Centro Medico
Buenos Aires, , Argentina
Fundación Respirar - Consultorios Médicos Dr. Doreski
Buenos Aires, , Argentina
Fundación Respirar Consultorio Médico Dr. Mariana Rivera
Buenos Aires, , Argentina
Investigaciones Reumatológicas y Osteológicas
Caba, , Argentina
Clínica Privada Vélez Sarsfield
Córdoba, , Argentina
Hospital Italiano La Plata
La Plata, , Argentina
Instituto de Reumatología
Mendoza, , Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, , Argentina
Centro Medico Privado de Reumatología
San Miguel de Tucumán, , Argentina
Medical Center Artmed
Plovdiv, , Bulgaria
Excelsior Medical Center
Sofia, , Bulgaria
Diagnostic Consultative Center Aleksandrovska
Sofia, , Bulgaria
Centro de Estudios Clínicos G y C
Providencia, , Chile
Centros de Estudios Reumatológicos (CER)
Providencia, , Chile
Centro Internacional de Estudios Clínicos
Recoleta, , Chile
Prosalud - Centro de Reumatología
Santiago, , Chile
CeCim - Centro de Estudios Clínicos e Investigaciones Médicas
Santiago, , Chile
Oncocentro APYS - Centro de Atención Médica Oncológica Integral
Viña del Mar, , Chile
Hôpital Lapeyronie
Montpellier, , France
Hôpital Emile Muller
Mulhouse, , France
Hôpital Hautepierre
Strasbourg, , France
New Plasma Clinic
Batumi, , Georgia
Aversi Clinic - Central Branch
Tbilisi, , Georgia
Jerarsi Clinic
Tbilisi, , Georgia
Caucasus Medical Center
Tbilisi, , Georgia
Clinic Innova LCC
Tbilisi, , Georgia
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
LMU Klinikum - Campus Innenstadt
München, , Germany
Praxis Für Rheumatologie, Gastroenterologie Und Innere Medizin
München, , Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, , Germany
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo
Budapest, , Hungary
Békés Megyei Központi Kórház - Pándy Kálmán Tagkórház
Gyula, , Hungary
Vital Medical Center - Reumatológia
Veszprém, , Hungary
Clínica San Juan de Dios
Cayma, , Peru
ACQ Medic S.A.C.
Jesús María, , Peru
Hospital Militar Central Coronel Luis Arias Schreiber
Jesús María, , Peru
Clínica Monterrico
Lima, , Peru
Instituto Peruano Del Hueso Y La Articulacion
San Isidro, , Peru
Clínica Anglo Americana - Sede San Isidro
San Isidro, , Peru
Hospital Maria Auxiliadora
San Juán de Miraflores, , Peru
Niepubliczny Zakład Opieki Zdrowotnej Bif-Med S.C.
Bytom, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Poradnie specjalistyczne REUMED Wallenroda
Lublin, , Poland
AES - Synexus - Poznań
Poznan, , Poland
Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
Poznan, , Poland
Trialmed CRS - Warszawa
Warsaw, , Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, , Poland
Klinika Reuma Park sp. z o.o. sp.k - Centrum Medyczne Reuma Park
Warsaw, , Poland
AES - Synexus - Wrocław
Wroclaw, , Poland
FutureMeds - Wroclaw
Wroclaw, , Poland
Latin Clinical Trial Center
San Juan, , Puerto Rico
GCM Medical Group
San Juan, , Puerto Rico
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional Universitario de Málaga - Hospital General
Málaga, , Spain
Hospital de Mérida
Mérida, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital Universitario Araba
Vitoria-Gasteiz, , Spain
Countries
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References
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Mammoliti O, Martina S, Claes P, Coti G, Blanque R, Jagerschmidt C, Shoji K, Borgonovi M, De Vos S, Marsais F, Oste L, Quinton E, Lopez-Ramos M, Amantini D, Brys R, Jimenez JM, Galien R, van der Plas S. Discovery of GLPG3667, a Selective ATP Competitive Tyrosine Kinase 2 Inhibitor for the Treatment of Autoimmune Diseases. J Med Chem. 2024 Jun 13;67(11):8545-8568. doi: 10.1021/acs.jmedchem.4c00769. Epub 2024 May 28.
Other Identifiers
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2023-503183-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
GLPG3667-CL-215
Identifier Type: -
Identifier Source: org_study_id