PER-007-23尚未招募3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with Active Lupus Nephritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Must have the ability to understand, sign, and date a written informed consent form (ICF), which must be obtained prior to initiation of study assessments
- •2. Adult male or female subjects, with a minimum age of 18 years (or legally or nationally defined per country specific definitions) to 75 years, inclusive, at screening
- •3. Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria, which include:
- •Antinuclear antibody (ANA) titer of at least 1:80 on Hep-2 cells or an equivalent positive test
- •=10 points from additive weighted criteria grouped in 7 criteria (constitutional, hematological, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and 3 immunological criteria (antiphospholipid antibodies, complement proteins, SLE-specific antibodies)
- •4. Active LN defined by renal biopsy criteria and proteinuria:
- •Kidney biopsy result within 6 months prior to screening, or, if not available, during screening (with results available prior to randomization) indicating International Society of Nephrology and the Renal Pathology Society 2003 Class III, IV-S, IV-G (alone or in combination with Class V),
- •UPCR =1.0 mg/mg (based on the 24-hour UPCR at screening)
- •5. In the opinion of the Investigator, the subject requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN
- •6. Subject is willing to take oral MMF for the duration of the study, either by continuing current MMF therapy or by initiating it on or before the Baseline Visit.
- •7. A female subject is eligible if she is not pregnant (i.e., after a confirmed menstrual period, a negative serum pregnancy test at screening and negative urine pregnancy test at the Baseline Visit), not breastfeeding (for at least 3 months prior to screening), and at least 1 of the following conditions applies:
- •Is not a woman of childbearing potential (WOCBP), as defined in Appendix 2.
- •Is a WOCBP who agrees to use a highly effective contraceptive method (i.e., has a failure rate of less than 1% per year), as listed in Appendix 2, at least 7 days prior to the Baseline Visit, 175 days after the last dose of study drug.
- •8. History of vaccinations, unless considered by the Investigator to be absolutely contraindicated due to a history of severe hypersensitivity reaction(s) to the vaccine(s) or any component of the vaccine(s), as follows:
- •Vaccination against S. pneumoniae with pneumococcal conjugate vaccine (PCV 13) or pneumococcal polysaccharide vaccine (PPSV23) with repeat administration as necessary to be up to date as per local guidelines
- •Vaccination against Influenza virus (as seasonally required)
- •Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- •Subjects receiving 1 or more of these vaccinations during screening must have at least 2 weeks between the vaccination(s) and the date of randomization. Live or live-attenuated vaccines are not permitted (Refer to the protocol Section 5.8.3.1).
排除标准
- •Key Exclusion Criteria:
- •1. eGFR as calculated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration equation of =30 mL/min/1.73 m2 at screening
- •2. Sclerosis in 50% of glomeruli on renal biopsy
- •3. Evidence of rapidly progressive glomerulonephritis (loss of =50% of eGFR within 3 months prior to screening)
- •4. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study
- •5. Severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis, or CNS vasculitis) requiring therapeutic intervention within 2 months prior to screening
- •6. Prior major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant or transplant is planned within the study period
- •7. History of or current overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (e.g., scleroderma with significant pulmonary hypertension; any condition for which additional immunosuppression is indicated). Sjögren’s syndrome secondary to SLE will not be excluded.
- •8. Laboratory abnormalities at screening:
- •Serum IgG below 7 g/L,
- •• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) > 2.5 × upper limit of normal (ULN) or total bilirubin >1.5 × ULN. Subjects with known history of Gilbert’s disease (abnormal total bilirubin which is predominately unconjugated bilirubin) must be approved by the Medical Monitor,
- •• White blood cell count (WBC) <2500/mm3; absolute neutrophil count (ANC) <1300/mm3; or thrombocytopenia (platelet count <50,000/mm3) at the Screening Visit
- •9. History of or current diagnosis of any demyelinating disease such as, but not restricted to, multiple sclerosis (MS) or optic neuritis (ON)
- •10. Any condition, including any clinically significant, uncontrolled current disease state other than LN or prior history of any medical condition, that, in the opinion of the Investigator or the Sponsor/designee, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluations, e.g., cardiovascular disease (congestive heart failure, cardiac arrhythmias, atherosclerotic heart disease, unstable angina), chronic obstructive pulmonary disease requiring treatment with oral corticosteroids; history of QT prolongation; active bleeding disorders
- •11. Any current medical condition other than LN requiring treatment with oral corticosteroids or immunosuppression
- •12. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test at screening:
- •If the subject is undergoing current treatment for LTBI, they must have received at least 4 continuous weeks of an appropriate LTBI treatment as per local guidelines prior to screening without evidence of re-exposure to be eligible for this study regardless of the Quantiferon result at screening. If the subject is on LTBI treatment at screening, they will be expected to complete an appropriate LTBI treatment regimen to remain in the trial o Subjects with current household contacts with active TB will be excluded unless prophylaxis treatment
研究者
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