MSV-ALLO for Lupus nephritis

Inclusion criteria

• {"criterion_text":"-Females or males aged ≥ 18 years who give written informed consent at the screening visit."}
• {"criterion_text":"-Systemic Lupus Erythematosus Diagnosis by meeting at least 4 criteria of the 11 included in ACR classification and/or SLICC criteria, at screening visit."}
• {"criterion_text":"-Lupus Nephritis Diagnosis according to 2003 International Society of Nephrology and Renal Pathology Society classification, by biopsy performed no more than 6 months prior to the screening visit if including from the induction period and performed no more than 1 year if including with moderate/severe recurrence."}
• {"criterion_text":"-No response, or partial response, to standard treatment, or moderate/severe recurrence of lupus nephritis"}
• {"criterion_text":"-SLEDAI-2K # 10 during the screening period"}
• {"criterion_text":"-Women of childbearing age must use effective methods of contraception to prevent pregnancy"}
• {"criterion_text":"-Have been vaccinated against pneumococcus and influenza at vaccination campaign time"}

Exclusion criteria

• {"criterion_text":"-*Previous treatments related: 1.-Use of corticosteroids or mycophenolate above allowed doses for induction, according to Systemic Autoimmune Diseases Group of Internal Medicine Spanish Society and Nephrology Spanish Society Consensus Document."}
• {"criterion_text":"-11. Diagnosis of active or latent tuberculosis by a purified protein derivative TB skin test (induration # 5 mm) or a positive Quantiferon test result, at screening or 3 months prior to the screening visit. Patients who have completed adequate prior treatment or who are receiving treatment will not repeat the test. Patients who are receiving adequate TB treatment for at least 4 continuous weeks prior to the screening visit and who are expected to complete the treatment regimen will not be excluded"}
• {"criterion_text":"-12. Presence of class 3 or 4 uncontrolled congestive heart failure according to the New York Heart Association"}
• {"criterion_text":"-2.- Use of rituximab, belimumab, ocrelizumab or other biological therapies against B cells 6 months prior to screening"}
• {"criterion_text":"-13. Active cancer"}
• {"criterion_text":"-14. Major surgical intervention within 6 weeks prior to the screening visit or planned during the trial period, including follow-up."}
• {"criterion_text":"-15. Pregnant or lactating women"}
• {"criterion_text":"-3.-Use of cyclophosphamide at any time during 6 months prior to selection."}
• {"criterion_text":"-4.- Use of any tumor necrosis factor inhibitor therapy at any time during 6 months prior to selection"}
• {"criterion_text":"-5.- Central nervous system SLE active considered severe or progressive (recent or uncontrolled seizures, anticonvulsant therapy changes in the 3 months prior to the screening visit, or leading to significant cognitive impairment)"}
• {"criterion_text":"-6.- Diagnosis of any demyelinating disease such as multiple sclerosis or optic neuritis"}
• {"criterion_text":"-3. Active cardiac arrhythmia or significant ECG clinical abnormalities at screening visit or on randomization day which, according to investigator, sponsor, or designee opinion, constitute an inappropriate risk or contraindication to study participation."}
• {"criterion_text":"-7.- Comorbidities that require treatment with systemic corticosteroids (oral, rectal or injectable) such as asthma or inflammatory bowel disease"}
• {"criterion_text":"-*Medical conditions related 1.- Any medical condition, including an uncontrolled disease other than SLE, that, in investigator opinion, sponsor or designee, represents an inappropriate risk or trials participation contraindication or would interfere with trial objectives , conduct or evaluation."}
• {"criterion_text":"-2. Cardiac, peripheral or cerebrovascular cardiovascular episodes during 6 months prior to screening visit."}
• {"criterion_text":"-*Laboratory abnormalities 1. Clinically significant abnormalities in laboratory tests not attributed to active SLE"}
• {"criterion_text":"-2. Chest X-ray significant abnormalities indicating active TB. The chest x-ray must have been done within 3 months prior to the screening visit or during the screening period."}
• {"criterion_text":"-*Other 1. Legal incapacity"}
• {"criterion_text":"-4. Thromboembolic episodes 12 months prior to or at screening visit, whether or not related to associated antiphospholipid syndrome, or inadequate anticoagulation testing 6 weeks immediately prior to or during the screening visit."}
• {"criterion_text":"-5. Central nervous system SLE active considered severe or progressive (recent or uncontrolled seizures, anticonvulsant therapy changes in the 3 months prior to the screening visit, or leading to significant cognitive impairment)."}
• {"criterion_text":"-6. Diagnosis of any demyelinating disease such as multiple sclerosis or optic neuritis."}
• {"criterion_text":"-7.Comorbidities that require treatment with systemic corticosteroids (oral, rectal or injectable) such as asthma or inflammatory bowel disease"}
• {"criterion_text":"-8. Previous or plans for organ transplantation"}
• {"criterion_text":"-9. Active viral, bacterial or fungal infection clinically significant, or any major episode of infection which required hospitalization or parenteral treatment in 4 weeks prior to the screening visit, during the screening visit, or anti-infective treatment completion in the 2 weeks prior to or during the screening visit, or recurrent infections (three or more same type of infection cases in a period of 12 consecutive months). Vaginal candidiasis, onychomycosis and controlled genital or oral herpes simplex virus would not be reasons for exclusion."}
• {"criterion_text":"-10. History or positive result for human immunodeficiency virus (HIV) test, hepatitis C antibodies and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg+), and/or total IgM antibodies to hepatitis B nuclear antigen at screening"}

Primary endpoints

• {"endpoint_text":"-The primary endpoint is the proportion of patients who have achieved complete response or partial response at week 24, relative to their baseline (treatment visit), in the treatment group compared to the placebo group.","definition_or_measurement_approach":"Proportion of patients achieving complete or partial response assessed at week 24 relative to baseline (treatment visit) comparing treatment versus placebo."}

Secondary endpoints

• {"endpoint_text":"-Proportion of patients at week 24 whose dose of prednisone-equivalent corticosteroids has been reduced relative to the screening visit by # 25% and to a dose # 7.5 mg/day and who have no exacerbation BILAG A or 2B . A BILAG A or 2B exacerbation is defined as at least one new BILAG A organic domain score or at least 2 new BILAG B organic domain scores compared to the screening visit.","definition_or_measurement_approach":"Measured at week 24: reduction in prednisone-equivalent dose by ≥25% to ≤7.5 mg/day and absence of BILAG A or 2B exacerbation (defined as ≥1 new BILAG A or ≥2 new BILAG B organic domain scores vs screening)."}
• {"endpoint_text":"-Proportion of patients at each visit whose prednisone-equivalent dose has been reduced relative to the screening visit by # 25% and at a dose # 7.5 mg/day, and who do not have any BILAG A or 2B exacerbations at the disease activity","definition_or_measurement_approach":"Assessed at each visit: proportion meeting prednisone-equivalent reduction ≥25% and ≤7.5 mg/day without BILAG A or 2B exacerbations."}
• {"endpoint_text":"-Proportion of patients at week 24 with a reduction relative to the screening visit in the daily dose of prednisone-equivalent corticosteroids of 0-<25%, 25%-50%, >50%.","definition_or_measurement_approach":"Categorical distribution of percent reduction in daily prednisone-equivalent dose at week 24 versus screening."}
• {"endpoint_text":"-Cumulative dose of prednisone-equivalent corticosteroids from the screening visit to week 24","definition_or_measurement_approach":"Total cumulative prednisone-equivalent dose calculated from screening through week 24."}
• {"endpoint_text":"-Proportion of patients who before week 24 have reduced the dose of immunosuppressants and who do not present any BILAG A or 2B exacerbation","definition_or_measurement_approach":"Proportion reducing immunosuppressant dose prior to week 24 without BILAG A or 2B exacerbation."}
• {"endpoint_text":"-Change from day 1 (treatment) in SF-36 and LupusQoL scores","definition_or_measurement_approach":"Change from baseline (day 1/treatment) in SF-36 and LupusQoL patient-reported outcome scores."}
• {"endpoint_text":"-Change from day 1 (treatment) in proteinuria levels","definition_or_measurement_approach":"Change from baseline (day 1/treatment) in proteinuria measurements."}
• {"endpoint_text":"-Change from day 1 (treatment) in the SLEDAI-2K index.","definition_or_measurement_approach":"Change from baseline (day 1/treatment) in SLEDAI-2K disease activity index."}

Spain

Earliest CTIS Part Ii Submission Date

23-05-2024

Latest Decision Or Authorization Date

20-11-2024

Processing Time Days

181

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Hospital Universitario Rio Hortega

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain