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New lupus pill shows promise in Mid-Stage trial

NCT ID NCT05856448

Disease control Sponsor: Lakefront Biotherapeutics NV Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral medication called GLPG3667 in 186 adults with active systemic lupus erythematosus (SLE). Participants took the drug or a placebo once daily for 48 weeks. The goal was to see if the drug could reduce lupus disease activity and improve symptoms, while monitoring safety and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

186 people

The number who actually took part.

Started

Jun 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • ACQ Medic S.A.C.

    Jesús María, 15072, Peru

  • AES - Synexus - Poznań

    Poznan, 60-702, Poland

  • AES - Synexus - Wrocław

    Wroclaw, 50-381, Poland

  • Advanced Pharma - Miami

    Miami, Florida, 33147, United States

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102, United States

  • Alliance Clinical Research of Tampa

    Tampa, Florida, 33615, United States

  • Alloy Clinical Research, LLC

    Kissimmee, Florida, 34741, United States

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180, United States

  • Aversi Clinic - Central Branch

    Tbilisi, 0160, Georgia

  • Békés Megyei Központi Kórház - Pándy Kálmán Tagkórház

    Gyula, 5700, Hungary

  • Care and Cure Clinic

    Houston, Texas, 77090, United States

  • Caucasus Medical Center

    Tbilisi, 0186, Georgia

  • CeCim - Centro de Estudios Clínicos e Investigaciones Médicas

    Santiago, 8330109, Chile

  • Centro Internacional de Estudios Clínicos

    Recoleta, 8420383, Chile

  • Centro Medico Privado de Reumatología

    San Miguel de Tucumán, T4000, Argentina

  • Centro de Estudios Clínicos G y C

    Providencia, 7500571, Chile

  • Centros de Estudios Reumatológicos (CER)

    Providencia, 7501126, Chile

  • Centrum Medyczne Plejady

    Krakow, 30-349, Poland

  • Clinic Innova LCC

    Tbilisi, 0186, Georgia

  • Clinica Adventista Belgrano

    Belgrano, C1430EGF, Argentina

  • Clínica Anglo Americana - Sede San Isidro

    San Isidro, 15073, Peru

  • Clínica Monterrico

    Lima, 15023, Peru

  • Clínica Privada Vélez Sarsfield

    Córdoba, 5016, Argentina

  • Clínica San Juan de Dios

    Cayma, 04017, Peru

  • DJL Clinical Research

    Charlotte, North Carolina, 28211, United States

  • Desert Medical Advances

    Rancho Mirage, California, 92270, United States

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, 1431, Bulgaria

  • Excelsior Medical Center

    Sofia, 1407, Bulgaria

  • Fundación Respirar - Consultorios Médicos Dr. Doreski

    Buenos Aires, 1426, Argentina

  • Fundación Respirar Consultorio Médico Dr. Mariana Rivera

    Buenos Aires, C1125 ABD, Argentina

  • FutureMeds - Wroclaw

    Wroclaw, 53-673, Poland

  • GCM Medical Group

    San Juan, 00917-3104, Puerto Rico

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Italiano La Plata

    La Plata, 1900, Argentina

  • Hospital Maria Auxiliadora

    San Juán de Miraflores, 15828, Peru

  • Hospital Militar Central Coronel Luis Arias Schreiber

    Jesús María, 15076, Peru

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, 29009, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Araba

    Vitoria-Gasteiz, 01009, Spain

  • Hospital Universitario Virgen de Valme

    Seville, 41014, Spain

  • Hospital Universitario de Badajoz

    Badajoz, 06080, Spain

  • Hospital de Mérida

    Mérida, 06800, Spain

  • Hôpital Emile Muller

    Mulhouse, 68100, France

  • Hôpital Hautepierre

    Strasbourg, 67098, France

  • Hôpital Lapeyronie

    Montpellier, 34090, France

  • Inland Rheumatology Clinical Trials

    Upland, California, 91786, United States

  • Instituto Peruano Del Hueso Y La Articulacion

    San Isidro, 15046, Peru

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, 1878, Argentina

  • Instituto de Reumatología

    Mendoza, 5500, Argentina

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida, 33324, United States

  • Investigaciones Reumatológicas y Osteológicas

    Caba, 1114, Argentina

  • Jerarsi Clinic

    Tbilisi, 0167, Georgia

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

    Warsaw, 02-665, Poland

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292, Germany

  • LMU Klinikum - Campus Innenstadt

    München, 80336, Germany

  • Latin Clinical Trial Center

    San Juan, 00909, Puerto Rico

  • Lynn Institute of Tulsa

    Tulsa, Oklahoma, 74135, United States

  • Maffei Centro Medico

    Buenos Aires, 1425, Argentina

  • Medical Center Artmed

    Plovdiv, 4002, Bulgaria

  • Millennium Clinical Trials

    Simi Valley, California, 93064, United States

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

    Warsaw, 02-637, Poland

  • New Phase Research & Development

    Knoxville, Tennessee, 37909, United States

  • New Plasma Clinic

    Batumi, 6010, Georgia

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

    Bytom, 41-902, Poland

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

    Memphis, Tennessee, 38119, United States

  • Omega Research DeBary

    DeBary, Florida, 32713, United States

  • Oncocentro APYS - Centro de Atención Médica Oncológica Integral

    Viña del Mar, 2520592, Chile

  • Poradnie specjalistyczne REUMED Wallenroda

    Lublin, 20-607, Poland

  • Praxis Für Rheumatologie, Gastroenterologie Und Innere Medizin

    München, 80639, Germany

  • Professional Research Center

    Miami, Florida, 33172, United States

  • Prosalud - Centro de Reumatología

    Santiago, 7510047, Chile

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

    Poznan, 61-397, Poland

  • Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo

    Budapest, 1036, Hungary

  • San Marcus Research Clinic

    Miami, Florida, 33014, United States

  • Southwest Arthritis

    Mesquite, Texas, 75150, United States

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • Trialmed CRS - Warszawa

    Warsaw, 02-482, Poland

  • University of Arizona College of Medicine - Tucson

    Tucson, Arizona, 85724, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40211, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

  • Upland Rheumatology Center

    Upland, California, 91786, United States

  • Vital Medical Center - Reumatológia

    Veszprém, 8200, Hungary

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