CERTOLIZUMAB PEGOL for Systemic lupus erythematosus (moderate or severe activity)

Inclusion criteria

• {"criterion_text":"- Signed informed consent form\n- Age 18-65 years\n- Ability to follow the study protocol\n- Documented diagnosis of SLE according to the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria at any time before or during screening\n- Positive antinuclear antibody (ANA) immunofluorescence test result with a titer of at least 1:80 AND Presence of at least one of the following serological markers of SLE at screening: ● Antibodies against double-stranded DNA (anti-dsDNA); OR ● Anti-Smith antibodies (anti-Sm)\n- At least moderate SLE activity, defined as meeting all of the following criteria: ● SELENA-SLEDAI score ≥4 indicating active disease ● Physician Global Assessment (PGA) ≥1.0 (on a scale of 0-3)\n- Acceptable medications and doses: ● Azathioprine: 1 to 2.5 mg/kg/day ● Methotrexate: 7.5 to 25 mg/week ● Mycophenolate mofetil: 500 to 3000 mg/day ● Hydroxychloroquine: 200 to 400 mg/day ● Chloroquine: 250 to 500 mg/day ● Leflunomide - 10-20 mg/day Patients treated with conventional medications should be on stable doses for ≥ 8 weeks prior to screening visit\n- Patients may receive standard treatment but no new therapy has been initiated or therapy has been withdrawn in the 8 weeks prior to the screening visit\n- If oral glucocorticosteroids (GCS) are used, the dose must be ≤20 mg/day prednisone (or equivalent) and must be stable for at least 2 weeks prior to study\n- Patients of childbearing potential should agree to abstinence or use a highly effective method of contraception during the entire study period and for at least 5 months after the last dose of certolizumab pegol or at least 4 months after the last dose of belimumab"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or breastfeeding\n- Patients who have ever received any of the study drugs in the past\n- Patients who received any of the following medications and/or procedures during the indicated time period: ● Plasmapheresis or intravenous immunoglobulin within the last 12 weeks prior to screening ● Lymphatic depleting therapy. B (e.g., anti-CD20 or anti-CD19) within 24 weeks prior to screening ● blisibimod, tabalumab (or other anti-B cell activating factor [BAFF] agents), atacicept, epratuzumab (or other anti-CD22 agents) within 5 half-lives or 12 weeks (whichever is longer) prior to screening ● cyclophosphamide or other alkylating agents within 12 weeks prior to screening ● oral cyclosporine, anakinra, tacrolimus, sirolimus, or other calcineurin inhibitors, topical calcineurin inhibitors within 4 weeks prior to screening ● thalidomide or thalidomide derivatives within 24 weeks prior to screening ● tumor necrosis factor (TNF) antagonists, tocilizumab or other biologics not listed previously used in the past. ● Any other immunosuppressive drug used for SLE not listed in the inclusion criteria within 12 weeks or 5 half-lives prior to screening, whichever is longer\n- Patients with active lupus nephritis: ● Proteinuria > 2 g/24 h or equivalent based on albumin/creatinine ratio (ACR) ● Active proliferative lupus nephritis (class III or IV TZN) based on renal biopsy performed within 6 months prior to screening (or during the study). ● Hemodialysis or high-dose corticosteroids (>100 mg/d prednisone or equivalent) for lupus erythematosus renal disease within 90 days of screening ● Serum creatinine > 2.0 mg/dL or estimated glomerular filtration rate ≤ 30 mL/min or chronic renal replacement therapy\n- Severe active central nervous system lupus erythematosus within 52 weeks of screening\n- Major surgery within 8 weeks prior to screening\n- Rheumatic disease other than systemic lupus erythematosus (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis) acceptable diagnosis of secondary Sjögren's syndrome\n- Immunization with a live or attenuated vaccine within 4 weeks prior to planned treatment\n- Known hypersensitivity to human, humanized or mouse monoclonal antibodies\n- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) >2 x ULN, if normalization occurs the patient may be considered for a repeat screening visit\n- Bilirubin >1.5 x GGN\n- History of severe bronchial asthma or other clinically significant pulmonary abnormalities\n- NYHA III/IV cardiovascular disease\n- Previous stroke, heart attack within 6 months prior to screening\n- Patients with chronic liver disease (Child Pugh A, B, C liver dysfunction)\n- Active or significant history of infection, including treatment with intravenous antibiotics in the last 4 weeks or oral antibiotics in the 2 weeks prior to screening\n- A positive SARS-CoV-2 test result during visit “0” is an exclusion criterion, while an infection more than 4 weeks before screening and confirmed by a negative SARS-CoV-2 test is not an exclusion criterion\n- Active confirmed tuberculosis or latent without chemoprophylaxis performed in accordance with applicable local recommendations\n- Active HBV, HCV infection (acceptable history of HCV after treatment and virus elimination confirmed by PCR test)\n- Human immunodeficiency virus (HIV) infection\n- Diagnosed primary or secondary immunodeficiency\n- Active or past malignancy within 5 years prior to screening, except resected/cured localized basal cell or squamous cell carcinoma of the skin or cervical cancer in situ\n- Hypogammaglobulinemia (IgG <400 mg/dl) or IgA (IgA <10 mg/dl) deficiency\n- Active or past drug or alcohol abuse\n- History of severe depression\n- The inability to understand and comply with the protocol requirements (lack of compliance) also excludes from participation in the study."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients who achieved an SRI-4 response defined as a decrease of ≥ 4 points on the SELENA-SLEDAI scale, no new BILAG A organ score and no more than 1 new BILAG B score, and no worsening (increase < 0.3) in the Physician Global Assessment (PGA) score from baseline at Week 52","definition_or_measurement_approach":"SRI-4 response defined as: decrease of ≥4 points on the SELENA-SLEDAI scale; no new BILAG A organ score; no more than 1 new BILAG B score; and no worsening (increase <0.3) in Physician Global Assessment (PGA) from baseline, assessed at Week 52."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients achieving SRI-4 response at week 52 with concomitant glucocorticosteroid dose reduction to <10 mg/d","definition_or_measurement_approach":"Proportion achieving SRI-4 at Week 52 plus concomitant reduction in glucocorticosteroid dose to <10 mg/day (prednisone equivalent)."}
• {"endpoint_text":"- Percentage of patients achieving SRI-4 response at week 26 with concomitant glucocorticosteroid dose reduction to <10 mg/d","definition_or_measurement_approach":"Proportion achieving SRI-4 at Week 26 plus concomitant reduction in glucocorticosteroid dose to <10 mg/day (prednisone equivalent)."}
• {"endpoint_text":"- Change from baseline in Physician Global Assessment of Disease Activity (PGA) at week 52","definition_or_measurement_approach":"Change from baseline in PGA score at Week 52."}
• {"endpoint_text":"- Change from Baseline in the 36-Item Short Form Health Survey (SF-36) Quality of Life Scale at Week 52","definition_or_measurement_approach":"Change from baseline in SF-36 score at Week 52."}
• {"endpoint_text":"- Percentage of patients achieving LLDAS (Lupus Low Disease Activity State) at week 52, defined as: ● SLEDAI-2k ≤4 and no disease activity in major organs (kidneys, central nervous system [CNS], heart, lungs), no vasculitis, fever, hemolytic anemia, gastrointestinal activity ● no new disease activity symptoms compared to previous assessment ● physician's global assessment of activity phPGA ≤1 on a 0-3 scale ● current dose of glucocorticosteroids in prednisone equivalent ≤7.5 mg/day ● well-tolerate","definition_or_measurement_approach":"LLDAS at Week 52 defined by criteria listed: SLEDAI-2k ≤4, no major organ activity, no new disease activity, phPGA ≤1 (0-3 scale), current glucocorticosteroid dose ≤7.5 mg/day prednisone equivalent."}
• {"endpoint_text":"- Change from baseline in fatigue at weeks 26 and 52 as measured by the FACIT fatigue score","definition_or_measurement_approach":"Change from baseline in FACIT-Fatigue score assessed at Weeks 26 and 52."}
• {"endpoint_text":"- Change from baseline in tender joint count (from 28 joints) at week 52","definition_or_measurement_approach":"Change from baseline in 28-joint tender joint count at Week 52."}
• {"endpoint_text":"- Change from baseline in number of swollen joints (of 28 joints) at week 52","definition_or_measurement_approach":"Change from baseline in 28-joint swollen joint count at Week 52."}
• {"endpoint_text":"- Reduction of skin lesions assessed according to the CLASI scale at week 52","definition_or_measurement_approach":"Change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) score from baseline to Week 52."}

Poland

Earliest CTIS Part Ii Submission Date

21-10-2025

Latest Decision Or Authorization Date

31-10-2025

Processing Time Days

10

Number Of Sites

4

Number Of Participants

90

Primary sponsor

Full Name

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"","full_name":"Agencja Badań Medycznych","duties_or_roles":"Source of monetary support","organisation_type":""}