PER-026-23RecruitingPhase 2
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
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Galapagos NV
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •* 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 (anti-dsDNA), decreased complement, thrombocytopenia, and leukopenia.
- •* 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 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.
- •For restrictions on these allowed treatments, see table in the Protocol
- •*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:
- •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.
Exclusion Criteria
- •* 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 SLE. *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, coccidiodmycosis, pneumocystosis, aspergillosis, herpes simplex, herpes zoster).
- •* Subject 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, subject is not eligible.
- •* 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).
- •* Subject has at screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 x ULN. Subjects with total bilirubin >1.5 x ULN, unless explicitly related to documented Gilbert’s syndrome or hemolysis.
- •* Subject has at screening a lymphocyte count of <0.7 × 10³/µL, and/or a platelet count of <75 x 10³/µL, and/or a neutrophil count of <1.5 × 10³/µL of blood, and/or hemoglobin <8 g/dL.
- •* 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.
- •*Subject 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. Subjects with pre-existing, controlled renal disease with serum creatinine <=2 x upper limit of normal (ULN) and either residual proteinuria u
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