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Systemic Lupus ErythematosusPhase 2GALACELANCT05856448

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

A Phase 2 study testing GLPG3667 in people with Systemic Lupus Erythematosus, run by Lakefront Biotherapeutics NV at 84 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
GLPG3667
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
84 sitesin 12 countries
Study dates
28 Jun 2023to 27 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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:
  • 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.

Who cannot join

  • 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).
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  • 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).
  • Prior exposure to tyrosine kinase 2 (TYK2) inhibitors.
  • Female participant is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.
  • Participant has taken any prohibited therapies within the defined washout periods before screening, and during screening.

Trial locations and contacts

84 sites in 12 countries.

84 sites in 12 countries

United States22 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • DJL Clinical Research

    Charlotte, North Carolina, 28211

  • Omega Research DeBary

    DeBary, Florida, 32713

  • Care and Cure Clinic

    Houston, Texas, 77090

  • Alloy Clinical Research, LLC

    Kissimmee, Florida, 34741

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • University of California San Diego

    La Jolla, California, 92037

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

    Memphis, Tennessee, 38119

  • Southwest Arthritis

    Mesquite, Texas, 75150

  • San Marcus Research Clinic

    Miami, Florida, 33014

  • Advanced Pharma - Miami

    Miami, Florida, 33147

  • Professional Research Center

    Miami, Florida, 33172

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida, 33324

  • Desert Medical Advances

    Rancho Mirage, California, 92270

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Millennium Clinical Trials

    Simi Valley, California, 93064

  • Alliance Clinical Research of Tampa

    Tampa, Florida, 33615

  • University of Arizona College of Medicine - Tucson

    Tucson, Arizona, 85724

  • Lynn Institute of Tulsa

    Tulsa, Oklahoma, 74135

  • Inland Rheumatology Clinical Trials

    Upland, California, 91786

  • Upland Rheumatology Center

    Upland, California, 91786

Other trials in United States

Argentina10 sites

  • Clinica Adventista Belgrano

    Belgrano, C1430EGF

  • Maffei Centro Medico

    Buenos Aires, 1425

  • Fundación Respirar - Consultorios Médicos Dr. Doreski

    Buenos Aires, 1426

  • Fundación Respirar Consultorio Médico Dr. Mariana Rivera

    Buenos Aires, C1125 ABD

  • Investigaciones Reumatológicas y Osteológicas

    Caba, 1114

  • Clínica Privada Vélez Sarsfield

    Córdoba, 5016

  • Hospital Italiano La Plata

    La Plata, 1900

  • Instituto de Reumatología

    Mendoza, 5500

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, 1878

  • Centro Medico Privado de Reumatología

    San Miguel de Tucumán, T4000

Other trials in Argentina

Poland10 sites

  • Niepubliczny Zakład Opieki Zdrowotnej Bif-Med S.C.

    Bytom, 41-902

  • Centrum Medyczne Plejady

    Krakow, 30-349

  • Poradnie specjalistyczne REUMED Wallenroda

    Lublin, 20-607

  • AES - Synexus - Poznań

    Poznan, 60-702

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

    Poznan, 61-397

  • Trialmed CRS - Warszawa

    Warsaw, 02-482

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

    Warsaw, 02-637

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

    Warsaw, 02-665

  • AES - Synexus - Wrocław

    Wroclaw, 50-381

  • FutureMeds - Wroclaw

    Wroclaw, 53-673

Other trials in Poland

Spain8 sites

  • Hospital Universitario de Badajoz

    Badajoz, 06080

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, 29009

  • Hospital de Mérida

    Mérida, 06800

  • Hospital Universitario Virgen de Valme

    Seville, 41014

  • Hospital Universitario Araba

    Vitoria-Gasteiz, 01009

Other trials in Spain

Peru7 sites

  • Clínica San Juan de Dios

    Cayma, 04017

  • ACQ Medic S.A.C.

    Jesús María, 15072

  • Hospital Militar Central Coronel Luis Arias Schreiber

    Jesús María, 15076

  • Clínica Monterrico

    Lima, 15023

  • Instituto Peruano Del Hueso Y La Articulacion

    San Isidro, 15046

  • Clínica Anglo Americana - Sede San Isidro

    San Isidro, 15073

  • Hospital Maria Auxiliadora

    San Juán de Miraflores, 15828

Other trials in Peru

Chile6 sites

  • Centro de Estudios Clínicos G y C

    Providencia, 7500571

  • Centros de Estudios Reumatológicos (CER)

    Providencia, 7501126

  • Centro Internacional de Estudios Clínicos

    Recoleta, 8420383

  • Prosalud - Centro de Reumatología

    Santiago, 7510047

  • CeCim - Centro de Estudios Clínicos e Investigaciones Médicas

    Santiago, 8330109

  • Oncocentro APYS - Centro de Atención Médica Oncológica Integral

    Viña del Mar, 2520592

Other trials in Chile

Georgia5 sites

  • New Plasma Clinic

    Batumi, 6010

  • Aversi Clinic - Central Branch

    Tbilisi, 0160

  • Jerarsi Clinic

    Tbilisi, 0167

  • Caucasus Medical Center

    Tbilisi, 0186

  • Clinic Innova LCC

    Tbilisi, 0186

Other trials in Georgia

Germany5 sites

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40211

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • LMU Klinikum - Campus Innenstadt

    München, 80336

  • Praxis Für Rheumatologie, Gastroenterologie Und Innere Medizin

    München, 80639

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

Other trials in Germany

Bulgaria3 sites

  • Medical Center Artmed

    Plovdiv, 4002

  • Excelsior Medical Center

    Sofia, 1407

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, 1431

Other trials in Bulgaria

France3 sites

  • Hôpital Lapeyronie

    Montpellier, 34090

  • Hôpital Emile Muller

    Mulhouse, 68100

  • Hôpital Hautepierre

    Strasbourg, 67098

Other trials in France

Hungary3 sites

  • Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo

    Budapest, 1036

  • Békés Megyei Központi Kórház - Pándy Kálmán Tagkórház

    Gyula, 5700

  • Vital Medical Center - Reumatológia

    Veszprém, 8200

Other trials in Hungary

Puerto Rico2 sites

  • Latin Clinical Trial Center

    San Juan, 00909

  • GCM Medical Group

    San Juan, 00917-3104

Other trials in Puerto Rico

About this study

Official title: 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).

Being tested
GLPG3667, Placebo
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLPG3667Drug

    Also called Cadefrecitinib

    Capsule

  • PlaceboDrug

    Capsule

Study groups in NCT05856448
Study groupRoleWhat they receive
GLPG3667 - Treatment AExperimentalParticipant will receive a dose A of GLPG3667 capsules orally once daily (q.d.) for 48 weeks.
Receives: Drug: GLPG3667
GLPG3667 - Treatment BExperimentalParticipant will receive a dose B of GLPG3667 capsules orally (q.d.) for 48 weeks.
Receives: Drug: GLPG3667
PlaceboPlacebo comparatorParticipant will receive placebo matched to GLPG3667 capsules orally q.d for 48 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 32

Secondary outcomes (11)

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

    Measured: Week 48

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

    Measured: Week 32, Week 48

  3. 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

    Measured: Week 32, Week 48

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

    Measured: Week 32, Week 48

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

    Measured: Baseline, Week 32 and Week 48

  6. Change from Baseline in the 28-joint Count for Swollen joints at Week 32 and Week 48

    Measured: Baseline, Week 32 and Week 48

  7. Change from Baseline in the 28-joint Count for Tender + Swollen (active) joints at Week 32 and Week 48

    Measured: Baseline, Week 32 and Week 48

  8. Number of Participants with Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs leading to treatment discontinuation

    Measured: From the start of first dose till 30 days after the last dose (up to 52 weeks)

  9. Pharmacokinetics (PK) of GLPG3667: Estimated Maximum Plasma Concentration (Cmax)

    Measured: 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

  10. PK of GLPG3667: Estimated Area Under the Concentration Time Curve (AUC) at Steady State

    Measured: 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

  11. PK of GLPG3667: Estimated Trough Concentration (Ctrough) at Steady State

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start28 Jun 2023
  3. Primary completion8 Oct 2025
  4. Study completion27 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856448
Sponsor's protocol ID
GLPG3667-CL-215
Other IDs
2023-503183-16-00, 2023
Acronym
GALACELA
Status last verified
Dec 2025
First submitted
3 May 2023
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 38805213

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLPG3667 in people with Systemic Lupus Erythematosus, run by Lakefront Biotherapeutics NV at 84 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Argentina, Poland, Spain, Peru and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieved the SLE Responder Index (SRI)-4 Response at Week 32 (time frame: Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05856448, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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