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

May 12, 2026 updated by: Galapagos NV

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Clinica Privada Velez 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 Medico Privado de Reumatologia
  • 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
        • Hopital Lapeyronie
      • Mulhouse, France, 68100
        • Hôpital 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 Brüder 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 Marañon
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants who Achieved the SLE Responder Index (SRI)-4 Response at Week 32
Time Frame: Week 32
Week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants who Achieved the SRI-4 Response at Week 48
Time Frame: 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
Time Frame: Week 32, 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
Time Frame: Week 32, Week 48
Week 32, Week 48
Percentage of Participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 32 and Week 48
Time Frame: Week 32, Week 48
Week 32, Week 48
Change from Baseline in the 28-joint Count for Tender joints at Week 32 and Week 48
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: From the start of first dose till 30 days after the last dose (up to 52 weeks)
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galapagos NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Galapagos Study Director, Galapagos NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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