Ended Therapeutic exploratory (Phase II) Systemic Lupus Erythematosus

A study evaluating the effects of GLPG3667 given as oral treatment in adults with active systemic lupus erythematosus.

EU CTIS ID: 2023-503183-16-00

What this study is testing

- To evaluate the efficacy of GLPG3667 compared to placebo on disease activity in subjects with active systemic lupus erythematosus (SLE).

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - Female or male subjects from 18 to 75 years of age inclusive, on the date of signing the informed consent form (ICF).
  • - Subject 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.
  • - Subject 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 (antidsDNA), decreased complement, thrombocytopenia, and leukopenia.
  • - Subject 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: (1) BILAG A or B score in the mucocutaneous body system; (2) BILAG A or B score in the musculoskeletal body system due to arthritis; (3) 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) 1 immunosuppressant (combination of immunosuppressants is not permitted), stable at least 8 weeks prior to screening; (2)1 antimalarial, stable at least 8 weeks prior to screening. In addition, oral CS (prednisone or equivalent) and/or NSAIDs background therapy is permitted but not required: (1) CS (prednisone or equivalent; <=30 mg/day; CS monotherapy is not permitted), stable at least 2 weeks prior to screening; AND/OR (2) Non-steroidal antiinflammatory drugs (NSAIDs; NSAIDs monotherapy is not permitted), stable at least 2 weeks prior to screening.

You likely can't join if

  • - Subject with active, severe lupus nephritis (World Health Organization Class III, IV) that requires or may require treatment with cytotoxic agents or high-dose corticosteroid are excluded. Subjects with pre-existing, controlled renal disease with serum creatinine <=2 x upper limit of normal (ULN) and either residual proteinuria up to 3 g/day or a urine protein: creatinine ratio (UPCR) of up to 3 mg/mg or 339 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.
  • - Subject with poorly controlled chronic cardiac, pulmonary, or renal disease.
  • - Subject 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 subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.
  • - Subject has taken any prohibited therapies within the defined washout periods before screening, and during screening.
See the full eligibility criteria
Who can join
  • - Female or male subjects from 18 to 75 years of age inclusive, on the date of signing the informed consent form (ICF).
  • - Subject 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.
  • - Subject 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 (antidsDNA), decreased complement, thrombocytopenia, and leukopenia.
  • - Subject 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: (1) BILAG A or B score in the mucocutaneous body system; (2) BILAG A or B score in the musculoskeletal body system due to arthritis; (3) 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) 1 immunosuppressant (combination of immunosuppressants is not permitted), stable at least 8 weeks prior to screening; (2)1 antimalarial, stable at least 8 weeks prior to screening. In addition, oral CS (prednisone or equivalent) and/or NSAIDs background therapy is permitted but not required: (1) CS (prednisone or equivalent; <=30 mg/day; CS monotherapy is not permitted), stable at least 2 weeks prior to screening; AND/OR (2) Non-steroidal antiinflammatory drugs (NSAIDs; NSAIDs monotherapy is not permitted), stable at least 2 weeks prior to screening.
What rules you out
  • - Subject with active, severe lupus nephritis (World Health Organization Class III, IV) that requires or may require treatment with cytotoxic agents or high-dose corticosteroid are excluded. Subjects with pre-existing, controlled renal disease with serum creatinine <=2 x upper limit of normal (ULN) and either residual proteinuria up to 3 g/day or a urine protein: creatinine ratio (UPCR) of up to 3 mg/mg or 339 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.
  • - Subject with poorly controlled chronic cardiac, pulmonary, or renal disease.
  • - Subject 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 subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.
  • - Subject has taken any prohibited therapies within the defined washout periods before screening, and during screening.
  • - Subjects with a history of catastrophic antiphospholipid syndrome are excluded. This includes subjects 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. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose are allowed.
  • - Subjects 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 subjects with mononeuritis multiplex and polyneuropathy, who are allowed.
  • - Drug-induced systemic lupus erythematosus.
  • - Subject has a chronic hepatitis B virus (HBV) infection, as defined by positive HBV surface antigen (HBsAg) at screening and detectable HBV core antibody (HBcAb).
  • - Subject has chronic hepatitis C virus (HCV) infection, as defined by positive HCV antibody (Ab) at screening and detectable HCV viremia. Subjects with positive HCV Ab must undergo reflex HCV ribonucleic acid (RNA) testing, and subjects with HCV RNA positivity will be excluded. Subjects with positive HCV Ab and negative HCV RNA are eligible.
  • - Subject 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).
  • - Subject 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 reverse transcription polymerase chain reaction (RT-PCR) test at screening and/or baseline (Day 1). Subject 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, dyspnea, 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.
  • - Subject meets 1 of the following tuberculosis (TB) criteria at screening: (1) A history of active or currently active TB (regardless of treatment). (2) 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, subject is not eligible.

The study team makes the final eligibility decision.

Where it's taking place

  • Argentina
  • United States
  • Mexico
  • Chile
  • Peru
  • Georgia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Argentina; United States; Mexico; Chile; Peru; Georgia. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.