A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus

NCT05856448 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GLPG3667-CL-2152023-503183-16-00
• Study Type: interventional
• Target: 186
• Locations: 12 countries
• Sites: 84

Brief Summary

A study evaluating the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG3667 administered orally once daily for 48 weeks in approximately 180 adult participants with active Systemic Lupus Erythematosus (SLE).

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieved the SLE Responder Index (SRI)-4 Response at Week 32

  Week 32

Secondary Outcomes (11)

• Percentage of Participants who Achieved the SRI-4 Response at Week 48

  Week 48

• Percentage of Participants who Achieved the British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 32 and Week 48

  Week 32, Week 48

• Percentage of Participants with >=50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 32 and Week 48

  Week 32, Week 48

• Percentage of Participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 32 and Week 48

  Week 32, Week 48

• Change from Baseline in the 28-joint Count for Tender joints at Week 32 and Week 48

  Baseline, Week 32 and Week 48

Study Arms (3)

GLPG3667 - Treatment A

EXPERIMENTAL

Participant will receive a dose A of GLPG3667 capsules orally once daily (q.d.) for 48 weeks.

Drug: GLPG3667

GLPG3667 - Treatment B

EXPERIMENTAL

Participant will receive a dose B of GLPG3667 capsules orally (q.d.) for 48 weeks.

Drug: GLPG3667

Placebo

PLACEBO COMPARATOR

Participant will receive placebo matched to GLPG3667 capsules orally q.d for 48 weeks.

Drug: Placebo

Interventions

GLPG3667 DRUG

Capsule

GLPG3667 - Treatment A; GLPG3667 - Treatment B

Placebo DRUG

Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant with documented diagnosis of SLE as defined by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria with a disease diagnosed ≥24 weeks before the screening visit.
• 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.
• 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.
• 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.
• 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:
• immunosuppressant (combination of immunosuppressants is not permitted), stable at least 8 weeks prior to screening.
• 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.

You may not qualify if:

• Participant with active, severe lupus nephritis (World Health Organization Class III, IV) that requires or may require treatment with cytotoxic agents or high-dose CS are excluded.
• 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.
• 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.
• 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.
• Drug-induced SLE.
• 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).
• 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.
• 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).
• 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.
• 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.
• Participant with poorly controlled chronic cardiac, pulmonary, or renal disease.
• 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).

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (84)

University of Arizona College of Medicine - Tucson

Tucson, Arizona, 85724, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Desert Medical Advances

Rancho Mirage, California, 92270, United States

Location

Millennium Clinical Trials

Simi Valley, California, 93064, United States

Location

Inland Rheumatology Clinical Trials

Upland, California, 91786, United States

Location

Upland Rheumatology Center

Upland, California, 91786, United States

Location

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

Omega Research DeBary

DeBary, Florida, 32713, United States

Location

Alloy Clinical Research, LLC

Kissimmee, Florida, 34741, United States

Location

San Marcus Research Clinic

Miami, Florida, 33014, United States

Location

Advanced Pharma - Miami

Miami, Florida, 33147, United States

Location

Professional Research Center

Miami, Florida, 33172, United States

Location

Integral Rheumatology & Immunology Specialists

Plantation, Florida, 33324, United States

Location

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28211, United States

Location

Lynn Institute of Tulsa

Tulsa, Oklahoma, 74135, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

Office of Ramesh C. Gupta MD / Shelby Research LLC - Tennessee

Memphis, Tennessee, 38119, United States

Location

Care and Cure Clinic

Houston, Texas, 77090, United States

Location

Southwest Arthritis

Mesquite, Texas, 75150, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Clinica Adventista Belgrano

Belgrano, C1430EGF, Argentina

Location

Maffei Centro Medico

Buenos Aires, 1425, Argentina

Location

Fundación Respirar - Consultorios Médicos Dr. Doreski

Buenos Aires, 1426, Argentina

Location

Fundación Respirar Consultorio Médico Dr. Mariana Rivera

Buenos Aires, C1125 ABD, Argentina

Location

Investigaciones Reumatológicas y Osteológicas

Caba, 1114, Argentina

Location

Clínica Privada Vélez Sarsfield

Córdoba, 5016, Argentina

Location

Hospital Italiano La Plata

La Plata, 1900, Argentina

Location

Instituto de Reumatología

Mendoza, 5500, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes

Quilmes, 1878, Argentina

Location

Centro Medico Privado de Reumatología

San Miguel de Tucumán, T4000, Argentina

Location

Medical Center Artmed

Plovdiv, 4002, Bulgaria

Location

Excelsior Medical Center

Sofia, 1407, Bulgaria

Location

Diagnostic Consultative Center Aleksandrovska

Sofia, 1431, Bulgaria

Location

Centro de Estudios Clínicos G y C

Providencia, 7500571, Chile

Location

Centros de Estudios Reumatológicos (CER)

Providencia, 7501126, Chile

Location

Centro Internacional de Estudios Clínicos

Recoleta, 8420383, Chile

Location

Prosalud - Centro de Reumatología

Santiago, 7510047, Chile

Location

CeCim - Centro de Estudios Clínicos e Investigaciones Médicas

Santiago, 8330109, Chile

Location

Oncocentro APYS - Centro de Atención Médica Oncológica Integral

Viña del Mar, 2520592, Chile

Location

Hôpital Lapeyronie

Montpellier, 34090, France

Location

Hôpital Emile Muller

Mulhouse, 68100, France

Location

Hôpital Hautepierre

Strasbourg, 67098, France

Location

New Plasma Clinic

Batumi, 6010, Georgia

Location

Aversi Clinic - Central Branch

Tbilisi, 0160, Georgia

Location

Jerarsi Clinic

Tbilisi, 0167, Georgia

Location

Caucasus Medical Center

Tbilisi, 0186, Georgia

Location

Clinic Innova LCC

Tbilisi, 0186, Georgia

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40211, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

LMU Klinikum - Campus Innenstadt

München, 80336, Germany

Location

Praxis Für Rheumatologie, Gastroenterologie Und Innere Medizin

München, 80639, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292, Germany

Location

Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo

Budapest, 1036, Hungary

Location

Békés Megyei Központi Kórház - Pándy Kálmán Tagkórház

Gyula, 5700, Hungary

Location

Vital Medical Center - Reumatológia

Veszprém, 8200, Hungary

Location

Clínica San Juan de Dios

Cayma, 04017, Peru

Location

ACQ Medic S.A.C.

Jesús María, 15072, Peru

Location

Hospital Militar Central Coronel Luis Arias Schreiber

Jesús María, 15076, Peru

Location

Clínica Monterrico

Lima, 15023, Peru

Location

Instituto Peruano Del Hueso Y La Articulacion

San Isidro, 15046, Peru

Location

Clínica Anglo Americana - Sede San Isidro

San Isidro, 15073, Peru

Location

Hospital Maria Auxiliadora

San Juán de Miraflores, 15828, Peru

Location

Niepubliczny Zakład Opieki Zdrowotnej Bif-Med S.C.

Bytom, 41-902, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-349, Poland

Location

Poradnie specjalistyczne REUMED Wallenroda

Lublin, 20-607, Poland

Location

AES - Synexus - Poznań

Poznan, 60-702, Poland

Location

Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj

Poznan, 61-397, Poland

Location

Trialmed CRS - Warszawa

Warsaw, 02-482, Poland

Location

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

Warsaw, 02-637, Poland

Location

Klinika Reuma Park sp. z o.o. sp.k - Centrum Medyczne Reuma Park

Warsaw, 02-665, Poland

Location

AES - Synexus - Wrocław

Wroclaw, 50-381, Poland

Location

FutureMeds - Wroclaw

Wroclaw, 53-673, Poland

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

GCM Medical Group

San Juan, 00917-3104, Puerto Rico

Location

Hospital Universitario de Badajoz

Badajoz, 06080, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario de Málaga - Hospital General

Málaga, 29009, Spain

Location

Hospital de Mérida

Mérida, 06800, Spain

Location

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

Location

Hospital Universitario Araba

Vitoria-Gasteiz, 01009, Spain

Location

Related Publications (1)

• 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.

  PMID: 38805213 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 12, 2023
• Study Start: June 28, 2023
• Primary Completion: October 8, 2025
• Study Completion: March 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); BU (3); DE (5); PL (10); PR (2); US (22); HU (3); ES (8); AR (10); CL (6); PE (7); GE (5)