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

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GLPG3667 in Adult Subjects With Active Systemic Lupus Erythematosus

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).

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Drug: GLPG3667

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Belgrano, Argentina, C1430EGF
    • Clinica Adventista Belgrano
  • Buenos Aires, Argentina, C1125 ABD
    • Fundación Respirar Consultorio Médico Dr. Mariana Rivera
  • Buenos Aires, Argentina, 1425
    • Maffei Centro Médico
  • Buenos Aires, Argentina, 1426
    • Fundación Respirar - Consultorios Médicos Dr. Doreski
  • Caba, Argentina, 1114
    • Investigaciones Reumatológicas y Osteológicas
  • Córdoba, Argentina, 5016
    • Clínica Privada Vélez Sarsfield
  • La Plata, Argentina, 1900
    • Hospital Italiano La Plata
  • Mendoza, Argentina, 5500
    • Instituto de Reumatologia
  • Quilmes, Argentina, 1878
    • Instituto de Investigaciones Clinicas Quilmes
  • San Miguel de Tucumán, Argentina, T4000
    • Centro Médico Privado de Reumatología
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Medical Center Artmed
  • Sofia, Bulgaria, 1407
    • Excelsior Medical Center
  • Sofia, Bulgaria, 1431
    • Diagnostic Consultative Center Aleksandrovska
• Chile
  • Providencia, Chile, 7500571
    • Centro de Estudios Clínicos G y C
  • Providencia, Chile, 7501126
    • Centros de Estudios Reumatológicos (CER)
  • Recoleta, Chile, 8420383
    • Centro Internacional de Estudios Clínicos
  • Santiago, Chile, 7510047
    • Prosalud - Centro de Reumatología
  • Santiago, Chile, 8330109
    • CeCim - Centro de Estudios Clínicos e Investigaciones Médicas
  • Viña del Mar, Chile, 2520592
    • Oncocentro APYS - Centro de Atención Médica Oncológica Integral
• France
  • Montpellier, France, 34090
    • Hôpital Lapeyronie
  • Mulhouse, France, 68100
    • Hopital Emile Muller
  • Strasbourg, France, 67098
    • Hôpital Hautepierre
• Georgia
  • Batumi, Georgia, 6010
    • New Plasma Clinic
  • Tbilisi, Georgia, 0167
    • Jerarsi Clinic
  • Tbilisi, Georgia, 0160
    • Aversi Clinic - Central Branch
  • Tbilisi, Georgia, 0186
    • Caucasus Medical Center
  • Tbilisi, Georgia, 0186
    • Clinic Innova LCC
• Germany
  • Düsseldorf, Germany, 40211
    • Universitätsklinikum Düsseldorf
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • München, Germany, 80336
    • LMU Klinikum - Campus Innenstadt
  • München, Germany, 80639
    • Praxis Für Rheumatologie, Gastroenterologie Und Innere Medizin
  • Trier, Germany, 54292
    • Krankenhaus der Barmherzigen Bruder Trier
• Hungary
  • Budapest, Hungary, 1036
    • Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo
  • Gyula, Hungary, 5700
    • Békés Megyei Központi Kórház - Pándy Kálmán Tagkórház
  • Veszprém, Hungary, 8200
    • Vital Medical Center - Reumatológia
• Peru
  • Cayma, Peru, 04017
    • Clínica San Juan de Dios
  • Jesús María, Peru, 15072
    • ACQ Medic S.A.C.
  • Jesús María, Peru, 15076
    • Hospital Militar Central Coronel Luis Arias Schreiber
  • Lima, Peru, 15023
    • Clínica Monterrico
  • San Isidro, Peru, 15046
    • Instituto Peruano Del Hueso Y La Articulacion
  • San Isidro, Peru, 15073
    • Clínica Anglo Americana - Sede San Isidro
  • San Juán de Miraflores, Peru, 15828
    • Hospital Maria Auxiliadora
• Poland
  • Bytom, Poland, 41-902
    • Niepubliczny Zakład Opieki Zdrowotnej Bif-Med S.C.
  • Krakow, Poland, 30-349
    • Centrum Medyczne Plejady
  • Lublin, Poland, 20-607
    • Poradnie specjalistyczne REUMED Wallenroda
  • Poznan, Poland, 60-702
    • AES - Synexus - Poznań
  • Poznan, Poland, 61-397
    • Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
  • Warsaw, Poland, 02-637
    • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
  • Warsaw, Poland, 02-482
    • Trialmed CRS - Warszawa
  • Warsaw, Poland, 02-665
    • Klinika Reuma Park sp. z o.o. sp.k - Centrum Medyczne Reuma Park
  • Wroclaw, Poland, 50-381
    • AES - Synexus - Wrocław
  • Wroclaw, Poland, 53-673
    • FutureMeds - Wroclaw
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center
  • San Juan, Puerto Rico, 00917-3104
    • GCM Medical Group
• Spain
  • Badajoz, Spain, 06080
    • Hospital Universitario de Badajoz
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Málaga, Spain, 29009
    • Hospital Regional Universitario de Malaga - Hospital General
  • Mérida, Spain, 06800
    • Hospital de Merida
  • Seville, Spain, 41014
    • Hospital Universitario Virgen De Valme
  • Vitoria-Gasteiz, Spain, 01009
    • Hospital Universitario Araba
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona College of Medicine - Tucson
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • Rancho Mirage, California, United States, 92270
      • Desert Medical Advances
    • Simi Valley, California, United States, 93064
      • Millennium Clinical Trials
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials
    • Upland, California, United States, 91786
      • Upland Rheumatology Center
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis & Rheumatic Disease Specialties
    • DeBary, Florida, United States, 32713
      • Omega Research DeBary
    • Kissimmee, Florida, United States, 34741
      • Alloy Clinical Research, LLC
    • Miami, Florida, United States, 33147
      • Advanced Pharma - Miami
    • Miami, Florida, United States, 33014
      • San Marcus Research Clinic
    • Miami, Florida, United States, 33172
      • Professional Research Center
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology & Immunology Specialists
    • Tampa, Florida, United States, 33615
      • Alliance Clinical Research of Tampa
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • DJL Clinical Research
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • Lynn Institute of Tulsa
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research & Development
    • Memphis, Tennessee, United States, 38119
      • Office of Ramesh C. Gupta MD / Shelby Research LLC - Tennessee
  • Texas
    • Houston, Texas, United States, 77090
      • Care and Cure Clinic
    • Mesquite, Texas, United States, 75150
      • Southwest Arthritis
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. 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.

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.

Key Exclusion Criteria:

1. 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG3667 - Treatment A; Participant will receive a dose A of GLPG3667 capsules orally once daily (q.d.) for 48 weeks.	Drug: GLPG3667; Capsule; Other Names: Cadefrecitinib
Experimental: GLPG3667 - Treatment B; Participant will receive a dose B of GLPG3667 capsules orally (q.d.) for 48 weeks.	Drug: GLPG3667; Capsule; Other Names: Cadefrecitinib
Placebo Comparator: Placebo; Participant will receive placebo matched to GLPG3667 capsules orally q.d for 48 weeks.	Drug: Placebo; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants who Achieved the SLE Responder Index (SRI)-4 Response at Week 32	Week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change from Baseline in the 28-joint Count for Swollen joints at Week 32 and Week 48	Baseline, Week 32 and Week 48
Change from Baseline in the 28-joint Count for Tender + Swollen (active) joints at Week 32 and Week 48	Baseline, Week 32 and Week 48
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs leading to treatment discontinuation	From the start of first dose till 30 days after the last dose (up to 52 weeks)
Pharmacokinetics (PK) of GLPG3667: Estimated Maximum Plasma Concentration (Cmax)	Predose every 4 weeks from Week 2 to Week 32 and 0.5hours (h)-2h , 2h-4h , 4h-6h postdose at Week 4, Predose every 8 weeks from Week 32 to Week 48
PK of GLPG3667: Estimated Area Under the Concentration Time Curve (AUC) at Steady State	Predose every 4 weeks from Week 2 to Week 32 and 0.5-2h , 2h-4h , 4h-6h postdose at Week 4, Predose every 8 weeks from Week 32 to Week 48
PK of GLPG3667: Estimated Trough Concentration (Ctrough) at Steady State	Predose every 4 weeks from Week 2 to Week 32 and 0.5-2h , 2h-4h , 4h-6h postdose at Week 4, Predose every 8 weeks from Week 32 to Week 48

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Galapagos Study Director, Galapagos NV

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Actual): October 8, 2025
• Study Completion (Actual): February 27, 2026

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: GLPG3667-CL-215; 2023-503183-16-00 (Ctis: CTIS - euclinicaltrials.eu)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No