A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Patients With Active Lupus
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 patients with active Lupus (SLE).
Conditions:
Systemic Lupus Erythematosus
Study Start (Actual) 2023-06-28
Primary Completion (Estimated) 2025-12
Study Completion (Estimated) 2026-04
Enrollment (Estimated) 180
Study Type INTERVENTIONAL
Phase PHASE2
Locations:
๐Ÿ“ Tucson, Arizona, United States
๐Ÿ“ La Jolla, California, United States
๐Ÿ“ Rancho Mirage, California, United States
๐Ÿ“ Simi Valley, California, United States
๐Ÿ“ Upland, California, United States
๐Ÿ“ Upland, California, United States
๐Ÿ“ Aventura, Florida, United States
๐Ÿ“ DeBary, Florida, United States
๐Ÿ“ Kissimmee, Florida, United States
๐Ÿ“ Miami, Florida, United States
๐Ÿ“ Miami, Florida, United States
๐Ÿ“ Miami, Florida, United States
๐Ÿ“ Plantation, Florida, United States
๐Ÿ“ Tampa, Florida, United States
๐Ÿ“ Albuquerque, New Mexico, United States
๐Ÿ“ Charlotte, North Carolina, United States
๐Ÿ“ Tulsa, Oklahoma, United States
๐Ÿ“ Knoxville, Tennessee, United States
๐Ÿ“ Memphis, Tennessee, United States
๐Ÿ“ Houston, Texas, United States
๐Ÿ“ Mesquite, Texas, United States
๐Ÿ“ San Antonio, Texas, United States
๐Ÿ“ Belgrano, Argentina
๐Ÿ“ Buenos Aires, Argentina
๐Ÿ“ Caba, Argentina
๐Ÿ“ Ciudad Autรณnoma de Buenos Aires, Argentina
๐Ÿ“ Ciudad Autรณnoma de Buenos Aires, Argentina
๐Ÿ“ Mendoza, Argentina
๐Ÿ“ Quilmes, Argentina
๐Ÿ“ San Miguel de Tucumรกn, Argentina
๐Ÿ“ Plovdiv, Bulgaria
๐Ÿ“ Sofia, Bulgaria
๐Ÿ“ Sofia, Bulgaria
๐Ÿ“ Providencia, Chile
๐Ÿ“ Recoleta, Chile
๐Ÿ“ Santiago, Chile
๐Ÿ“ Viรฑa del Mar, Chile
๐Ÿ“ Montpellier, France
๐Ÿ“ Mulhouse, France
๐Ÿ“ Strasbourg, France
๐Ÿ“ Batumi, Georgia
๐Ÿ“ Tbilisi, Georgia
๐Ÿ“ Tbilisi, Georgia
๐Ÿ“ Tbilisi, Georgia
๐Ÿ“ Tbilisi, Georgia
๐Ÿ“ Mainz, Germany
๐Ÿ“ Mรผnchen, Germany
๐Ÿ“ Mรผnchen, Germany
๐Ÿ“ Trier, Germany
๐Ÿ“ Budapest, Hungary
๐Ÿ“ Veszprรฉm, Hungary
๐Ÿ“ Cayma, Peru
๐Ÿ“ Jesรบs Marรญa, Peru
๐Ÿ“ Lima, Peru
๐Ÿ“ Bytom, Poland
๐Ÿ“ Krakรณw, Poland
๐Ÿ“ Lublin, Poland
๐Ÿ“ Poznaล„, Poland
๐Ÿ“ Warszawa, Poland
๐Ÿ“ Warszawa, Poland
๐Ÿ“ Warszawa, Poland
๐Ÿ“ Wrocล‚aw, Poland
๐Ÿ“ Wrocล‚aw, Poland
๐Ÿ“ San Juan, Puerto Rico
๐Ÿ“ Badajoz, Spain
๐Ÿ“ Madrid, Spain
๐Ÿ“ Madrid, Spain
๐Ÿ“ Mรกlaga, Spain
๐Ÿ“ Mรฉrida, Spain
๐Ÿ“ Sevilla, Spain
๐Ÿ“ Vitoria-Gasteiz, Spain

Eligibility Criteria

Description

    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 โ‰ฅ24 weeks before the screening visit.
    • 2. Participant has a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score โ‰ฅ6 points and a clinical SLEDAI-2K score โ‰ฅ4 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) โ‰ฅ1:80 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.

    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 creatinineโ‰ฅ 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 QuantiFERONยฎ-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.
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

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 Registration Dates

  • First Submitted2023-05-03
  • First Submitted that Met QC Criteria2023-05-04
  • First Posted2023-05-12

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-07-17
  • Last Update Posted2024-07-18
  • Last Verified2024-07